Trial Outcomes & Findings for Efficacy Study of Fluconazole to Treat Coccidioidomycosis Pneumonia (Valley Fever) (NCT NCT02663674)
NCT ID: NCT02663674
Last Updated: 2019-07-05
Results Overview
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
TERMINATED
PHASE4
72 participants
Visit 2 (Day 20-23)
2019-07-05
Participant Flow
Recruitment occurred between Feb 2016 and May 2018 at community locations in Coccidioides-endemic areas. Participants were adults presenting with community acquired pneumonia (CAP) whose health care provider had made the decision to treat with an antibacterial.
Participant milestones
| Measure |
Fluconazole
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
39
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
Fluconazole
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Other Event (Health Related)
|
0
|
1
|
Baseline Characteristics
Efficacy Study of Fluconazole to Treat Coccidioidomycosis Pneumonia (Valley Fever)
Baseline characteristics by cohort
| Measure |
Fluconazole
n=33 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=39 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
39 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Positive for coccidioidomycosis pneumonia
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected capsules.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci-positive Per-protocol Population
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=3 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population
|
20 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The population includes all participants who took at least one dose of study medication.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication
|
20 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Visit 2 - Visit 4 (Day 20-46)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Visit 2 - Visit 4 (Day 20-46)Population: The population includes all participants who took at least one dose of study medication.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication
|
25 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Visit 2 - Visit 4 (Day 20-46)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population
|
25 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Total FLEET CAP Score
|
3.04 score on a scale
Interval 1.0 to 5.0
|
3.49 score on a scale
Interval 1.0 to 6.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Cough
|
0.85 score on a scale
Interval 0.0 to 2.0
|
0.86 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fatigue
|
0.74 score on a scale
Interval 0.0 to 1.0
|
0.74 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Chest Pain
|
0.11 score on a scale
Interval 0.0 to 0.0
|
0.31 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Dyspnea
|
0.48 score on a scale
Interval 0.0 to 1.0
|
0.60 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Sputum Production
|
0.41 score on a scale
Interval 0.0 to 1.0
|
0.40 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Night Sweats
|
0.26 score on a scale
Interval 0.0 to 0.0
|
0.37 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hypoxia
|
0.19 score on a scale
Interval 0.0 to 0.0
|
0.20 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Total FLEET CAP Score
|
2.00 score on a scale
Interval 1.0 to 5.0
|
2.00 score on a scale
Interval 1.0 to 6.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Cough
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fatigue
|
1 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=26 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=31 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Total FLEET CAP Score
|
2.58 score on a scale
Interval 0.0 to 4.0
|
1.97 score on a scale
Interval 0.0 to 2.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Cough
|
0.73 score on a scale
Interval 0.0 to 1.0
|
0.48 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fatigue
|
0.62 score on a scale
Interval 0.0 to 1.0
|
0.42 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Chest Pain
|
0.19 score on a scale
Interval 0.0 to 0.0
|
0.13 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Dyspnea
|
0.46 score on a scale
Interval 0.0 to 1.0
|
0.42 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Sputum Production
|
0.31 score on a scale
Interval 0.0 to 0.0
|
0.16 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Night Sweats
|
0.15 score on a scale
Interval 0.0 to 0.0
|
0.19 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hypoxia
|
0.12 score on a scale
Interval 0.0 to 0.0
|
0.16 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=26 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=31 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Total FLEET CAP Score
|
2 score on a scale
Interval 0.0 to 4.0
|
1 score on a scale
Interval 0.0 to 2.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Cough
|
1 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fatigue
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Total FLEET CAP Score
|
1.36 score on a scale
Interval 0.0 to 2.0
|
1.5 score on a scale
Interval 0.0 to 2.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Cough
|
0.44 score on a scale
Interval 0.0 to 1.0
|
0.23 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fatigue
|
0.36 score on a scale
Interval 0.0 to 1.0
|
0.37 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Chest Pain
|
0.08 score on a scale
Interval 0.0 to 0.0
|
0.17 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Dyspnea
|
0.12 score on a scale
Interval 0.0 to 0.0
|
0.30 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Sputum Production
|
0.24 score on a scale
Interval 0.0 to 0.0
|
0.13 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Night Sweats
|
0.04 score on a scale
Interval 0.0 to 0.0
|
0.10 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hypoxia
|
0.08 score on a scale
Interval 0.0 to 0.0
|
0.20 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Total FLEET CAP Score
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Cough
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fatigue
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=3 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
2.25 score on a scale
Interval 1.0 to 3.5
|
3.67 score on a scale
Interval 0.0 to 10.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Cough
|
0.5 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 0.0 to 2.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fatigue
|
1.00 score on a scale
Interval 0.5 to 1.5
|
1.00 score on a scale
Interval 0.0 to 3.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0.67 score on a scale
Interval 0.0 to 2.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0.33 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0.67 score on a scale
Interval 0.0 to 2.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=3 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
1 score on a scale
Interval 1.0 to 3.5
|
1 score on a scale
Interval 0.0 to 10.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Cough
|
0 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 0.0 to 2.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fatigue
|
1 score on a scale
Interval 0.5 to 1.5
|
0 score on a scale
Interval 0.0 to 3.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 2.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
1.00 score on a scale
Interval 0.0 to 2.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Cough
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fatigue
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0.5 score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
0.5 score on a scale
Interval 0.0 to 2.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Cough
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fatigue
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 0.5
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
0.75 score on a scale
Interval 0.0 to 1.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Cough
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fatigue
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
0 score on a scale
Interval 0.0 to 1.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Cough
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fatigue
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
3.04 score on a scale
Interval 1.0 to 5.0
|
3.49 score on a scale
Interval 1.0 to 6.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Cough
|
0.85 score on a scale
Interval 0.0 to 2.0
|
0.86 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fatigue
|
0.74 score on a scale
Interval 0.0 to 1.0
|
0.74 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0.11 score on a scale
Interval 0.0 to 0.0
|
0.31 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0.48 score on a scale
Interval 0.0 to 1.0
|
0.6 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0.41 score on a scale
Interval 0.0 to 1.0
|
0.40 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0.26 score on a scale
Interval 0.0 to 0.0
|
0.37 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0.19 score on a scale
Interval 0.0 to 0.0
|
0.20 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 6.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Cough
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fatigue
|
1 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=26 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=31 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
2.58 score on a scale
Interval 0.0 to 4.0
|
1.97 score on a scale
Interval 0.0 to 2.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Cough
|
0.73 score on a scale
Interval 0.0 to 1.0
|
0.48 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fatigue
|
0.62 score on a scale
Interval 0.0 to 1.0
|
0.42 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0.19 score on a scale
Interval 0.0 to 0.0
|
0.13 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0.46 score on a scale
Interval 0.0 to 1.0
|
0.42 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0.31 score on a scale
Interval 0.0 to 0.0
|
0.16 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0.15 score on a scale
Interval 0.0 to 0.0
|
0.19 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0.12 score on a scale
Interval 0.0 to 0.0
|
0.16 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=26 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=31 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
2 score on a scale
Interval 0.0 to 4.0
|
1 score on a scale
Interval 0.0 to 2.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Cough
|
1 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fatigue
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
1.36 score on a scale
Interval 0.0 to 2.0
|
1.5 score on a scale
Interval 0.0 to 2.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Cough
|
0.44 score on a scale
Interval 0.0 to 1.0
|
0.23 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fatigue
|
0.36 score on a scale
Interval 0.0 to 1.0
|
0.37 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0.08 score on a scale
Interval 0.0 to 0.0
|
0.17 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0.12 score on a scale
Interval 0.0 to 0.0
|
0.30 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0.24 score on a scale
Interval 0.0 to 0.0
|
0.13 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0.04 score on a scale
Interval 0.0 to 0.0
|
0.10 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0.08 score on a scale
Interval 0.0 to 0.0
|
0.20 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Total FLEET CAP Score
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Cough
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fatigue
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Total FLEET CAP Score
|
2.25 score on a scale
Interval 1.0 to 3.5
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Cough
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fatigue
|
1.00 score on a scale
Interval 0.5 to 1.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Dyspnea
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Night Sweats
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Total FLEET CAP Score
|
1 score on a scale
Interval 1.0 to 3.5
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Cough
|
0 score on a scale
Interval 0.0 to 1.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fatigue
|
1 score on a scale
Interval 0.5 to 1.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Total FLEET CAP Score
|
1.00 score on a scale
Interval 0.0 to 2.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Cough
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fatigue
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Dyspnea
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 0.5
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Total FLEET CAP Score
|
0.5 score on a scale
Interval 0.0 to 2.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Cough
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fatigue
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Total FLEET CAP Score
|
0.75 score on a scale
Interval 0.0 to 1.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Cough
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fatigue
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hypoxia
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Cough
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Total FLEET CAP Score
|
0 score on a scale
Interval 0.0 to 1.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fatigue
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=29 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Total FLEET CAP Score
|
2.64 score on a scale
Interval 1.0 to 4.0
|
3.72 score on a scale
Interval 1.0 to 6.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Cough
|
0.80 score on a scale
Interval 0.0 to 1.0
|
0.97 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fatigue
|
0.72 score on a scale
Interval 0.0 to 1.0
|
0.76 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Chest Pain
|
0.08 score on a scale
Interval 0.0 to 0.0
|
0.34 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Dyspnea
|
0.40 score on a scale
Interval 0.0 to 1.0
|
0.66 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Sputum Production
|
0.32 score on a scale
Interval 0.0 to 1.0
|
0.45 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Night Sweats
|
0.16 score on a scale
Interval 0.0 to 0.0
|
0.38 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hypoxia
|
0.16 score on a scale
Interval 0.0 to 0.0
|
0.17 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=29 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Total FLEET CAP Score
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 6.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Cough
|
1 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fatigue
|
1 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=25 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fatigue
|
0.63 score on a scale
Interval 0.0 to 1.0
|
0.44 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Dyspnea
|
0.42 score on a scale
Interval 0.0 to 1.0
|
0.44 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Sputum Production
|
0.33 score on a scale
Interval 0.0 to 0.5
|
0.16 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Total FLEET CAP Score
|
2.42 score on a scale
Interval 0.0 to 3.5
|
1.96 score on a scale
Interval 0.0 to 2.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Cough
|
0.71 score on a scale
Interval 0.0 to 1.0
|
0.48 score on a scale
Interval 0.0 to 1.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Chest Pain
|
0.17 score on a scale
Interval 0.0 to 0.0
|
0.12 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Night Sweats
|
0.08 score on a scale
Interval 0.0 to 0.0
|
0.20 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hypoxia
|
0.08 score on a scale
Interval 0.0 to 0.0
|
0.12 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=25 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fatigue
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Total FLEET CAP Score
|
2 score on a scale
Interval 0.0 to 3.5
|
1 score on a scale
Interval 0.0 to 2.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Cough
|
1 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=23 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=24 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Cough
|
0.35 score on a scale
Interval 0.0 to 1.0
|
0.21 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Chest Pain
|
0.04 score on a scale
Interval 0.0 to 0.0
|
0.13 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Sputum Production
|
0.13 score on a scale
Interval 0.0 to 0.0
|
0.08 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Night Sweats
|
0.04 score on a scale
Interval 0.0 to 0.0
|
0.08 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Total FLEET CAP Score
|
1.09 score on a scale
Interval 0.0 to 2.0
|
1.25 score on a scale
Interval 0.0 to 2.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fatigue
|
0.35 score on a scale
Interval 0.0 to 1.0
|
0.38 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Dyspnea
|
0.09 score on a scale
Interval 0.0 to 0.0
|
0.21 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hypoxia
|
0.09 score on a scale
Interval 0.0 to 0.0
|
0.17 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=23 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=24 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fatigue
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Chest Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Total FLEET CAP Score
|
0 score on a scale
Interval 0.0 to 2.0
|
0.5 score on a scale
Interval 0.0 to 2.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Cough
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Dyspnea
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Sputum Production
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Night Sweats
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Fever
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hypoxia
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1) through Visit 4 (Day 42-46)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
Number of the days of school or work missed due to illness by participant self-report
Outcome measures
| Measure |
Fluconazole
n=19 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=23 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of the Days of School or Work Missed Due to Illness in the ITT Population
|
0 days
Standard Deviation 0
|
1.5 days
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1) through Visit 4 (Day 42-46)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Number of the days of school or work missed due to illness by participant self-report
Outcome measures
| Measure |
Fluconazole
n=2 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of the Days of School or Work Missed Due to Illness in the Cocci Positive mITT Population
|
0 days
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1) through Visit 4 (Day 42-46)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
Number of the days of school or work missed due to illness by participant self-report
Outcome measures
| Measure |
Fluconazole
n=18 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=17 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of the Days of School or Work Missed Due to Illness in the All Randomized PP Population
|
0 days
Standard Deviation 0
|
0.6 days
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1) through Visit 4 (Day 42-46)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
Number of the days of school or work missed due to illness by participant self-report
Outcome measures
| Measure |
Fluconazole
n=2 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of the Days of School or Work Missed Due to Illness in the Cocci Positive PP Population
|
0 days
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1) through Visit 4 (Day 42-46)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Number of the days of school or work missed due to illness by participant self-report
Outcome measures
| Measure |
Fluconazole
n=19 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=23 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of the Days of School or Work Missed Due to Illness in the All Randomized mITT Population
|
0 days
Standard Deviation 0
|
1.5 days
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Always
|
15 Participants
|
13 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Usually
|
5 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Rarely
|
5 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
7 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Usually
|
4 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Never
|
1 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Sometimes
|
7 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Usually
|
3 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Rarely
|
3 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Sometimes
|
4 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Always
|
15 Participants
|
15 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Always
|
11 Participants
|
13 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Never
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Rarely
|
3 Participants
|
2 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Sometimes
|
5 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Usually
|
4 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Always
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=26 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=31 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Sometimes
|
6 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Usually
|
4 Participants
|
13 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Always
|
13 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Usually
|
5 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Rarely
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Rarely
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Sometimes
|
6 Participants
|
11 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Usually
|
4 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Always
|
14 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Rarely
|
4 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
5 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Usually
|
4 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Always
|
13 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Rarely
|
2 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Sometimes
|
6 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Always
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Always
|
14 Participants
|
12 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Rarely
|
2 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Sometimes
|
5 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Usually
|
4 Participants
|
11 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Usually
|
4 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Sometimes
|
6 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Usually
|
4 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Usually
|
2 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Always
|
16 Participants
|
15 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Never
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Rarely
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
5 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Always
|
14 Participants
|
11 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Rarely
|
2 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Sometimes
|
5 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Always
|
14 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Visit 6 (Day 83-97)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Never
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 7 (Day 173-187)Population: The Intent-to-Treat (ITT) population includes all randomized participants.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Usually
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Usually
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Usually
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Always
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Usually
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Always
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Usually
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Always
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Usually
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Always
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Usually
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Always
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
2 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
2 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
2 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 6 (Day 83-97)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Never
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 7 (Day 173-187)Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Usually
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=3 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Usually
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Usually
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Always
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Always
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Usually
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Always
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Usually
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Always
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Usually
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Always
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Usually
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
2 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
2 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Visit 6 (Day 83-97)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Never
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 7 (Day 173-187)Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Usually
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=29 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Sometimes
|
7 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Usually
|
3 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Always
|
14 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Rarely
|
2 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Sometimes
|
4 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Usually
|
5 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Always
|
14 Participants
|
11 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Rarely
|
5 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Sometimes
|
5 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Usually
|
4 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Always
|
11 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
2 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Rarely
|
3 Participants
|
2 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Sometimes
|
5 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Usually
|
4 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Always
|
13 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=25 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Usually
|
4 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Rarely
|
4 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Always
|
12 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Rarely
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Sometimes
|
5 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Usually
|
4 Participants
|
13 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Always
|
12 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Rarely
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Sometimes
|
5 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Always
|
13 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Sometimes
|
4 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Usually
|
4 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Always
|
12 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Rarely
|
2 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Sometimes
|
5 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Usually
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=23 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=24 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Sometimes
|
5 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Usually
|
4 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Always
|
13 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Rarely
|
2 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Rarely
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Usually
|
4 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Sometimes
|
4 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Usually
|
2 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Always
|
15 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Never
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Sometimes
|
4 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Always
|
13 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Rarely
|
2 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Sometimes
|
4 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Usually
|
4 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Always
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Visit 6 (Day 83-97)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Never
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 7 (Day 173-187)Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing family activities I want to do · Usually
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Never
|
1 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
7 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Rarely
|
3 Participants
|
2 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Sometimes
|
5 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Always
|
14 Participants
|
12 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Sometimes
|
7 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Usually
|
3 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Always
|
15 Participants
|
13 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Rarely
|
3 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Sometimes
|
4 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Usually
|
5 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Always
|
15 Participants
|
15 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Rarely
|
5 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Usually
|
4 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Always
|
11 Participants
|
13 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Never
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Usually
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 27-30)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=26 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=31 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Rarely
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Sometimes
|
6 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Always
|
13 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Sometimes
|
6 Participants
|
7 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Usually
|
5 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Always
|
13 Participants
|
11 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Usually
|
4 Participants
|
13 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Rarely
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Sometimes
|
6 Participants
|
11 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Usually
|
4 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Always
|
14 Participants
|
9 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Rarely
|
4 Participants
|
3 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
5 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Usually
|
4 Participants
|
10 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Always
|
13 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Rarely
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 42-46)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Usually
|
4 Participants
|
8 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Usually
|
2 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Usually
|
4 Participants
|
11 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Sometimes
|
6 Participants
|
6 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Always
|
14 Participants
|
12 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Rarely
|
2 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Sometimes
|
5 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Always
|
16 Participants
|
15 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Never
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Rarely
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
5 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Always
|
14 Participants
|
11 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Rarely
|
2 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Sometimes
|
5 Participants
|
5 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Usually
|
4 Participants
|
4 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Always
|
14 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Visit 6 (Day 83-97)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Never
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 7 (Day 173-187)Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing regular leisure activities w others · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Usually
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing family activities I want to do · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Sometimes
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing usual work (incl work at home) · Always
|
3 Participants
|
1 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Never
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Sometimes
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Usually
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
Trouble doing activities with friends I want to do · Always
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 43Population: The population includes all participants who took at least one dose of study medication.
Mortality information was obtained through medical records or next of kin.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
Incidence Rate of All-cause Mortality
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 20-23)Population: Intent-to-Treat (ITT) population - This efficacy analysis population includes all randomized participants.
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants, Regardless of Coccidioidomycosis Status or Adherence to Study Drug
|
20 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=32 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=39 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
48.2 score on a scale
Standard Deviation 10.1
|
49.0 score on a scale
Standard Deviation 10.2
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
38.6 score on a scale
Standard Deviation 11.1
|
39.7 score on a scale
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Day 22Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
51.4 score on a scale
Standard Deviation 10.0
|
49.4 score on a scale
Standard Deviation 10.7
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
45.4 score on a scale
Standard Deviation 11.2
|
44.2 score on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Day 29Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=26 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=31 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
49.5 score on a scale
Standard Deviation 10.6
|
50.6 score on a scale
Standard Deviation 9.9
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
47.9 score on a scale
Standard Deviation 10.5
|
46.2 score on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Day 43Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
52.4 score on a scale
Standard Deviation 10.0
|
51.3 score on a scale
Standard Deviation 8.7
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
50.1 score on a scale
Standard Deviation 8.9
|
46.2 score on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Day 90Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
51.5 score on a scale
Standard Deviation 13.1
|
49.5 score on a scale
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
52.9 score on a scale
Standard Deviation 9.0
|
55.5 score on a scale
|
SECONDARY outcome
Timeframe: Day 180Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
55.3 score on a scale
Standard Deviation 9.8
|
61.1 score on a scale
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
46.9 score on a scale
Standard Deviation 9.1
|
57.7 score on a scale
|
SECONDARY outcome
Timeframe: Day 1Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
MCS
|
52.0 score on a scale
Standard Deviation 6.3
|
37.1 score on a scale
Standard Deviation 8.3
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
PCS
|
46.2 score on a scale
Standard Deviation 15.4
|
45.3 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Day 22Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
MCS
|
51.6 score on a scale
Standard Deviation 8.3
|
43.7 score on a scale
Standard Deviation 9.6
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
PCS
|
49.6 score on a scale
Standard Deviation 12.3
|
60.1 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Day 29Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
MCS
|
54.0 score on a scale
Standard Deviation 11.3
|
43.9 score on a scale
Standard Deviation 24.3
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
PCS
|
51.6 score on a scale
Standard Deviation 11.0
|
60.1 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Day 43Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
MCS
|
53.6 score on a scale
Standard Deviation 12.2
|
50.2 score on a scale
Standard Deviation 15.5
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
PCS
|
53.6 score on a scale
Standard Deviation 7.0
|
58.9 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Day 90Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
MCS
|
51.5 score on a scale
Standard Deviation 13.1
|
49.5 score on a scale
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
PCS
|
52.9 score on a scale
Standard Deviation 9.0
|
55.5 score on a scale
|
SECONDARY outcome
Timeframe: Day 180Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
MCS
|
55.3 score on a scale
Standard Deviation 9.8
|
61.1 score on a scale
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
PCS
|
46.9 score on a scale
Standard Deviation 9.1
|
57.7 score on a scale
|
SECONDARY outcome
Timeframe: Day 1Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=4 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
MCS
|
52.0 score on a scale
Standard Deviation 6.3
|
39.0 score on a scale
Standard Deviation 12.3
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
PCS
|
46.2 score on a scale
Standard Deviation 15.4
|
42.2 score on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Day 22Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=3 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
MCS
|
51.6 score on a scale
Standard Deviation 8.3
|
40.6 score on a scale
Standard Deviation 8.7
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
PCS
|
49.6 score on a scale
Standard Deviation 12.3
|
47.4 score on a scale
Standard Deviation 22.1
|
SECONDARY outcome
Timeframe: Day 29Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
MCS
|
54.0 score on a scale
Standard Deviation 11.3
|
43.9 score on a scale
Standard Deviation 24.3
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
PCS
|
51.6 score on a scale
Standard Deviation 11.0
|
60.1 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Day 43Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
MCS
|
53.6 score on a scale
Standard Deviation 12.2
|
50.2 score on a scale
Standard Deviation 15.5
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
PCS
|
53.6 score on a scale
Standard Deviation 7.0
|
58.9 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Day 90Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
PCS
|
52.9 score on a scale
Standard Deviation 9.0
|
55.5 score on a scale
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
MCS
|
51.5 score on a scale
Standard Deviation 13.1
|
49.5 score on a scale
|
SECONDARY outcome
Timeframe: Day 180Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
MCS
|
55.3 score on a scale
Standard Deviation 9.8
|
61.1 score on a scale
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
PCS
|
46.9 score on a scale
Standard Deviation 9.1
|
57.7 score on a scale
|
SECONDARY outcome
Timeframe: Day 1Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=29 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
49.1 score on a scale
Standard Deviation 10.2
|
47.9 score on a scale
Standard Deviation 9.5
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
39.4 score on a scale
Standard Deviation 11.6
|
39.6 score on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Day 22Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=29 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
51.7 score on a scale
Standard Deviation 9.3
|
49.6 score on a scale
Standard Deviation 10.8
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
45.9 score on a scale
Standard Deviation 11.3
|
43.2 score on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Day 29Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=25 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
50.5 score on a scale
Standard Deviation 10.2
|
50.8 score on a scale
Standard Deviation 10.3
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
48.3 score on a scale
Standard Deviation 10.7
|
45.3 score on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Day 43Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=22 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=24 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
53.3 score on a scale
Standard Deviation 10.0
|
49.8 score on a scale
Standard Deviation 9.0
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
50.5 score on a scale
Standard Deviation 9.1
|
46.0 score on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Day 90Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
51.5 score on a scale
Standard Deviation 13.1
|
49.5 score on a scale
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
52.9 score on a scale
Standard Deviation 9.0
|
55.5 score on a scale
|
SECONDARY outcome
Timeframe: Day 180Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
55.3 score on a scale
Standard Deviation 9.8
|
61.1 score on a scale
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
46.9 score on a scale
Standard Deviation 9.1
|
57.7 score on a scale
|
SECONDARY outcome
Timeframe: Day 1Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=32 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=39 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
48.2 score on a scale
Standard Deviation 10.1
|
49.0 score on a scale
Standard Deviation 10.2
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
38.6 score on a scale
Standard Deviation 11.1
|
39.7 score on a scale
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Day 22Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
51.4 score on a scale
Standard Deviation 10.0
|
49.4 score on a scale
Standard Deviation 10.7
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
45.4 score on a scale
Standard Deviation 11.2
|
44.2 score on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Day 29Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=26 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=31 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
49.5 score on a scale
Standard Deviation 10.6
|
50.6 score on a scale
Standard Deviation 9.9
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
47.9 score on a scale
Standard Deviation 10.5
|
46.2 score on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Day 43Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
52.4 score on a scale
Standard Deviation 10.0
|
51.3 score on a scale
Standard Deviation 8.7
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
50.1 score on a scale
Standard Deviation 8.9
|
46.2 score on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Day 90Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
51.5 score on a scale
Standard Deviation 13.1
|
49.5 score on a scale
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
52.9 score on a scale
Standard Deviation 9.0
|
55.5 score on a scale
|
SECONDARY outcome
Timeframe: Day 180Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
55.3 score on a scale
Standard Deviation 9.8
|
61.1 score on a scale
|
|
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
46.9 score on a scale
Standard Deviation 9.1
|
57.7 score on a scale
|
SECONDARY outcome
Timeframe: Day 1Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=32 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=39 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
50.0 score on a scale
Interval 41.1 to 56.4
|
49.6 score on a scale
Interval 42.0 to 56.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
39.1 score on a scale
Interval 30.1 to 45.2
|
39.1 score on a scale
Interval 31.9 to 46.7
|
SECONDARY outcome
Timeframe: Day 22Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
54.9 score on a scale
Interval 44.5 to 59.1
|
50.5 score on a scale
Interval 43.1 to 59.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
46.5 score on a scale
Interval 35.5 to 55.7
|
46.0 score on a scale
Interval 33.4 to 56.0
|
SECONDARY outcome
Timeframe: Day 29Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=26 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=31 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
54.5 score on a scale
Interval 40.2 to 57.8
|
52.9 score on a scale
Interval 43.1 to 58.2
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
52.5 score on a scale
Interval 39.3 to 57.2
|
47.5 score on a scale
Interval 36.8 to 57.2
|
SECONDARY outcome
Timeframe: Day 43Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
56.4 score on a scale
Interval 43.1 to 60.2
|
54.1 score on a scale
Interval 46.6 to 59.0
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
53.5 score on a scale
Interval 44.8 to 56.7
|
48.6 score on a scale
Interval 41.2 to 53.8
|
SECONDARY outcome
Timeframe: Day 90Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
56.4 score on a scale
Interval 44.3 to 58.8
|
49.5 score on a scale
Interval 49.5 to 49.5
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
57.2 score on a scale
Interval 48.3 to 57.5
|
55.5 score on a scale
Interval 55.5 to 55.5
|
SECONDARY outcome
Timeframe: Day 180Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
MCS
|
59.2 score on a scale
Interval 49.2 to 61.5
|
61.1 score on a scale
Interval 61.1 to 61.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
PCS
|
50.9 score on a scale
Interval 41.7 to 52.1
|
57.7 score on a scale
Interval 57.7 to 57.7
|
SECONDARY outcome
Timeframe: Day 1Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
MCS
|
52.7 score on a scale
Interval 46.8 to 57.2
|
37.1 score on a scale
Interval 31.3 to 43.0
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
PCS
|
51.2 score on a scale
Interval 35.0 to 57.4
|
45.3 score on a scale
Interval 43.9 to 46.7
|
SECONDARY outcome
Timeframe: Day 22Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
MCS
|
54.5 score on a scale
Interval 46.7 to 56.5
|
43.7 score on a scale
Interval 36.9 to 50.5
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
PCS
|
53.5 score on a scale
Interval 42.2 to 57.0
|
60.1 score on a scale
Interval 59.0 to 61.1
|
SECONDARY outcome
Timeframe: Day 29Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
MCS
|
58.8 score on a scale
Interval 46.9 to 61.2
|
43.9 score on a scale
Interval 26.8 to 61.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
PCS
|
56.7 score on a scale
Interval 45.6 to 57.5
|
60.1 score on a scale
Interval 57.7 to 62.5
|
SECONDARY outcome
Timeframe: Day 43Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
MCS
|
58.8 score on a scale
Interval 46.0 to 61.2
|
50.2 score on a scale
Interval 39.2 to 61.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
PCS
|
56.7 score on a scale
Interval 49.7 to 57.5
|
58.9 score on a scale
Interval 57.7 to 60.1
|
SECONDARY outcome
Timeframe: Day 90Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
MCS
|
56.4 score on a scale
Interval 44.3 to 58.8
|
49.5 score on a scale
Interval 49.5 to 49.5
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
PCS
|
57.2 score on a scale
Interval 48.3 to 57.5
|
55.5 score on a scale
Interval 55.5 to 55.5
|
SECONDARY outcome
Timeframe: Day 180Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
MCS
|
59.2 score on a scale
Interval 49.2 to 61.5
|
61.1 score on a scale
Interval 61.1 to 61.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
PCS
|
50.9 score on a scale
Interval 41.7 to 52.1
|
57.7 score on a scale
Interval 57.7 to 57.7
|
SECONDARY outcome
Timeframe: Day 1Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=4 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
MCS
|
52.7 score on a scale
Interval 46.8 to 57.2
|
37.1 score on a scale
Interval 29.3 to 48.8
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
PCS
|
51.2 score on a scale
Interval 35.0 to 57.4
|
45.3 score on a scale
Interval 35.6 to 48.9
|
SECONDARY outcome
Timeframe: Day 22Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=3 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
MCS
|
54.5 score on a scale
Interval 46.7 to 56.5
|
36.9 score on a scale
Interval 34.4 to 50.5
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
PCS
|
53.5 score on a scale
Interval 42.2 to 57.0
|
59.0 score on a scale
Interval 21.9 to 61.1
|
SECONDARY outcome
Timeframe: Day 29Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
MCS
|
58.8 score on a scale
Interval 46.9 to 61.2
|
43.9 score on a scale
Interval 26.8 to 61.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
PCS
|
56.7 score on a scale
Interval 45.6 to 57.5
|
60.1 score on a scale
Interval 57.7 to 62.5
|
SECONDARY outcome
Timeframe: Day 43Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=2 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
MCS
|
58.8 score on a scale
Interval 46.0 to 61.2
|
50.2 score on a scale
Interval 39.2 to 61.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
PCS
|
56.7 score on a scale
Interval 49.7 to 57.5
|
58.9 score on a scale
Interval 57.7 to 60.1
|
SECONDARY outcome
Timeframe: Day 90Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
MCS
|
56.4 score on a scale
Interval 44.3 to 58.8
|
49.5 score on a scale
Interval 49.5 to 49.5
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
PCS
|
57.2 score on a scale
Interval 48.3 to 57.5
|
55.5 score on a scale
Interval 55.5 to 55.5
|
SECONDARY outcome
Timeframe: Day 180Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
MCS
|
59.2 score on a scale
Interval 49.2 to 61.5
|
61.1 score on a scale
Interval 61.1 to 61.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
PCS
|
50.9 score on a scale
Interval 41.7 to 52.1
|
57.7 score on a scale
Interval 57.7 to 57.7
|
SECONDARY outcome
Timeframe: Day 1Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=29 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
51.1 score on a scale
Interval 44.4 to 56.4
|
47.9 score on a scale
Interval 40.7 to 54.9
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
39.7 score on a scale
Interval 31.1 to 46.5
|
39.2 score on a scale
Interval 31.9 to 46.1
|
SECONDARY outcome
Timeframe: Day 22Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=25 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=29 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
54.9 score on a scale
Interval 44.7 to 58.5
|
50.5 score on a scale
Interval 43.1 to 59.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
48.3 score on a scale
Interval 36.3 to 55.7
|
45.3 score on a scale
Interval 33.4 to 53.2
|
SECONDARY outcome
Timeframe: Day 29Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=25 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
55.6 score on a scale
Interval 42.9 to 58.3
|
53.3 score on a scale
Interval 44.2 to 58.2
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
52.9 score on a scale
Interval 40.0 to 57.2
|
46.9 score on a scale
Interval 36.8 to 54.8
|
SECONDARY outcome
Timeframe: Day 43Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=22 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=24 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
57.2 score on a scale
Interval 51.7 to 61.1
|
49.6 score on a scale
Interval 43.3 to 58.4
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
54.0 score on a scale
Interval 46.3 to 57.2
|
48.2 score on a scale
Interval 38.5 to 53.6
|
SECONDARY outcome
Timeframe: Day 90Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
56.4 score on a scale
Interval 44.3 to 58.8
|
49.5 score on a scale
Interval 49.5 to 49.5
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
57.2 score on a scale
Interval 48.3 to 57.5
|
55.5 score on a scale
Interval 55.5 to 55.5
|
SECONDARY outcome
Timeframe: Day 180Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
MCS
|
59.2 score on a scale
Interval 49.2 to 61.5
|
61.1 score on a scale
Interval 61.1 to 61.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
PCS
|
50.9 score on a scale
Interval 41.7 to 52.1
|
57.7 score on a scale
Interval 57.7 to 57.7
|
SECONDARY outcome
Timeframe: Day 1Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=32 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=39 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
50.0 score on a scale
Interval 41.1 to 56.4
|
49.6 score on a scale
Interval 42.0 to 56.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
39.1 score on a scale
Interval 30.1 to 45.2
|
39.1 score on a scale
Interval 31.9 to 46.7
|
SECONDARY outcome
Timeframe: Day 22Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=27 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=35 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
54.9 score on a scale
Interval 44.5 to 59.1
|
50.5 score on a scale
Interval 43.1 to 59.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
46.5 score on a scale
Interval 35.5 to 55.7
|
46.0 score on a scale
Interval 33.4 to 56.0
|
SECONDARY outcome
Timeframe: Day 29Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=26 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=31 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
54.5 score on a scale
Interval 40.2 to 57.8
|
52.9 score on a scale
Interval 43.1 to 58.2
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
52.5 score on a scale
Interval 39.3 to 57.2
|
47.5 score on a scale
Interval 36.8 to 57.2
|
SECONDARY outcome
Timeframe: Day 43Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=24 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=30 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
56.4 score on a scale
Interval 43.1 to 60.2
|
54.1 score on a scale
Interval 46.6 to 59.0
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
53.5 score on a scale
Interval 44.8 to 56.7
|
48.6 score on a scale
Interval 41.2 to 53.8
|
SECONDARY outcome
Timeframe: Day 90Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
56.4 score on a scale
Interval 44.3 to 58.8
|
49.5 score on a scale
Interval 49.5 to 49.5
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
57.2 score on a scale
Interval 48.3 to 57.5
|
55.5 score on a scale
Interval 55.5 to 55.5
|
SECONDARY outcome
Timeframe: Day 180Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Outcome measures
| Measure |
Fluconazole
n=4 Participants
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
|
Placebo
n=1 Participants
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
|
|---|---|---|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
MCS
|
59.2 score on a scale
Interval 49.2 to 61.5
|
61.1 score on a scale
Interval 61.1 to 61.1
|
|
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
PCS
|
50.9 score on a scale
Interval 41.7 to 52.1
|
57.7 score on a scale
Interval 57.7 to 57.7
|
Adverse Events
Fluconazole
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emmanuel Walter, M.D., M.P.H.
Duke Clinical Vaccine Unit
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60