Trial Outcomes & Findings for The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP) (NCT NCT00809328)
NCT ID: NCT00809328
Last Updated: 2011-05-19
Results Overview
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
COMPLETED
PHASE3
102 participants
End of Treatment, Day 15 and Day 29
2011-05-19
Participant Flow
Participant milestones
| Measure |
Azithromycin
Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Azithromycin
Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
|
|---|---|
|
Overall Study
Lack of Efficacy
|
18
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
Baseline characteristics by cohort
| Measure |
Azithromycin
n=102 Participants
Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
|
|---|---|
|
Age Continuous
|
55.4 years
STANDARD_DEVIATION 18.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: End of Treatment, Day 15 and Day 29Population: Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. "n " in the measured values means total participants excluding ones assessed as indeterminate.
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
Outcome measures
| Measure |
Azithromycin
n=73 Participants
Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
|
|---|---|
|
Response Rate (Clinical Response, Data Review Committee Assessment)
End of Treatment (n=73)
|
86.3 percentage of participants
Interval 76.2 to 93.2
|
|
Response Rate (Clinical Response, Data Review Committee Assessment)
Day 15 (Primary analysis ) (n=71)
|
84.5 percentage of participants
Interval 74.0 to 92.0
|
|
Response Rate (Clinical Response, Data Review Committee Assessment)
Day 29 (n=70)
|
82.9 percentage of participants
Interval 72.0 to 90.8
|
SECONDARY outcome
Timeframe: End of Treatment, Day 15 and Day 29Population: Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. "n " in the measured values means total participants excluding ones assessed as indeterminate.
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100
Outcome measures
| Measure |
Azithromycin
n=73 Participants
Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
|
|---|---|
|
Response Rate (Clinical Response, Investigator Assessment)
End of Treatment (n=73)
|
80.8 percentage of participants
Interval 69.9 to 89.1
|
|
Response Rate (Clinical Response, Investigator Assessment)
Day 15 (n=62)
|
98.4 percentage of participants
Interval 91.3 to 100.0
|
|
Response Rate (Clinical Response, Investigator Assessment)
Day 29 (n=61)
|
95.1 percentage of participants
Interval 86.3 to 99.0
|
SECONDARY outcome
Timeframe: Day 3Population: Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.
The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 3, and was determined to continue the treatment.
Outcome measures
| Measure |
Azithromycin
n=73 Participants
Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
|
|---|---|
|
The Tendency Toward Clinical Improvement (Investigator Assessment)
|
68 participants
|
SECONDARY outcome
Timeframe: Day 3, End of Treatment, Day 15 and Day 29Population: Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. "n " in the measured values was the total participants EXCLUDING ones assessed as indeterminate.
Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100
Outcome measures
| Measure |
Azithromycin
n=33 Participants
Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
|
|---|---|
|
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Day 3 (n=28)
|
71.4 percentage of participants
Interval 51.3 to 86.8
|
|
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
End of Treatment (n=31)
|
80.6 percentage of participants
Interval 62.5 to 92.5
|
|
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Day 15 (n=30)
|
83.3 percentage of participants
Interval 65.3 to 94.4
|
|
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Day 29 (n=30)
|
83.3 percentage of participants
Interval 65.3 to 94.4
|
SECONDARY outcome
Timeframe: Day 3, End of Treatment, Day 15 and Day 29Population: Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. "n " in the measured values was the total participants EXCLUDING ones assessed as indeterminate.
Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100
Outcome measures
| Measure |
Azithromycin
n=33 Participants
Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
|
|---|---|
|
Eradication Rate (Bacteriological Response, Investigator Assessment)
Day 3 (n=27)
|
74.1 percentageof participants
Interval 53.7 to 88.9
|
|
Eradication Rate (Bacteriological Response, Investigator Assessment)
End of Treatment (n=29)
|
86.2 percentageof participants
Interval 68.3 to 96.1
|
|
Eradication Rate (Bacteriological Response, Investigator Assessment)
Day 15 (n=25)
|
100.0 percentageof participants
Interval 86.3 to 100.0
|
|
Eradication Rate (Bacteriological Response, Investigator Assessment)
Day 29 (n=25)
|
100.0 percentageof participants
Interval 86.3 to 100.0
|
Adverse Events
Azithromycin
Serious adverse events
| Measure |
Azithromycin
n=102 participants at risk
Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
|
|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Peritonsillar abscess
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
2.9%
3/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Prothrombin time prolonged
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Azithromycin
n=102 participants at risk
Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
7.8%
8/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.7%
15/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site erythema
|
2.9%
3/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site pain
|
5.9%
6/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
3/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
7.8%
8/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
5.9%
6/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.9%
3/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER