Trial Outcomes & Findings for ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir (NCT NCT02609399)
NCT ID: NCT02609399
Last Updated: 2019-10-04
Results Overview
Symptom evaluation during the 2015-2016 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms. Item responses: 1. Not at all 2. A little bit 3. Somewhat 4. Quite a bit 5. Very much
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
ED Enrollment Visit through Day 14 ( 2015-2016 influenza season)
Results posted on
2019-10-04
Participant Flow
This study recruited adult patients through both clinical testing and screening with a Clinical Decision Guideline (CDG) over two influenza seasons at the following academically affiliated U.S. Emergency Departments (EDs): * November 2015- April 2016: Johns Hopkins Hospital (JHH) * November 2016- April 2017: JHH and Maricopa Medical Center (MMC)
Participant milestones
| Measure |
Oseltamivir
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
|
Peramivir
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
|
|---|---|---|
|
Influenza Season 2015-2016
STARTED
|
27
|
31
|
|
Influenza Season 2015-2016
COMPLETED
|
24
|
29
|
|
Influenza Season 2015-2016
NOT COMPLETED
|
3
|
2
|
|
Influenza Season 2016-2017
STARTED
|
58
|
64
|
|
Influenza Season 2016-2017
COMPLETED
|
49
|
59
|
|
Influenza Season 2016-2017
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
Oseltamivir
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
|
Peramivir
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
|
|---|---|---|
|
Influenza Season 2015-2016
Lost to Follow-up
|
3
|
2
|
|
Influenza Season 2016-2017
Lost to Follow-up
|
8
|
5
|
|
Influenza Season 2016-2017
Found ineligible after randomization
|
1
|
0
|
Baseline Characteristics
This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
Baseline characteristics by cohort
| Measure |
Experimental: Oseltamivir
n=84 Participants
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
|
Experimental: Peramivir
n=95 Participants
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir.
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.3 years
n=84 Participants
|
47.5 years
n=95 Participants
|
47.4 years
n=179 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=84 Participants
|
58 Participants
n=95 Participants
|
106 Participants
n=179 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=84 Participants
|
37 Participants
n=95 Participants
|
73 Participants
n=179 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=84 Participants
|
19 Participants
n=95 Participants
|
29 Participants
n=179 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=84 Participants
|
76 Participants
n=95 Participants
|
150 Participants
n=179 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=84 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=179 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=84 Participants
|
2 Participants
n=95 Participants
|
3 Participants
n=179 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=84 Participants
|
1 Participants
n=95 Participants
|
3 Participants
n=179 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=84 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=179 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=84 Participants
|
60 Participants
n=95 Participants
|
120 Participants
n=179 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=84 Participants
|
29 Participants
n=95 Participants
|
50 Participants
n=179 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=84 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=179 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=84 Participants
|
3 Participants
n=95 Participants
|
3 Participants
n=179 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=84 Participants
|
95 participants
n=95 Participants
|
179 participants
n=179 Participants
|
|
Age, Continuous (Influenza Season 2015-2016)
|
48.7 years
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
43.7 years
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
46 years
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Age, Continuous (Influenza Season 2016-2017)
|
46.6 years
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm.
|
49.3 years
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm.
|
48.0 years
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm.
|
|
Sex: Female, Male (Influenza Season 2015-2016)
Female
|
11 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
17 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
28 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Sex: Female, Male (Influenza Season 2015-2016)
Male
|
16 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
14 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
30 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Sex: Female, Male (Influenza Season 2016-2017)
Female
|
37 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
41 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
78 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
|
Sex: Female, Male (Influenza Season 2016-2017)
Male
|
20 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
23 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
43 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
|
Ethnicity (NIH/OMB) (Influenza Season 2015-2016)
Hispanic or Latino
|
0 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
0 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
0 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Ethnicity (NIH/OMB) (Influenza Season 2015-2016)
Not Hispanic or Latino
|
27 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
31 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
58 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Ethnicity (NIH/OMB) (Influenza Season 2016-2017)
Hispanic or Latino
|
10 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
19 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
29 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
|
Ethnicity (NIH/OMB) (Influenza Season 2016-2017)
Not Hispanic or Latino
|
47 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
45 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
92 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
|
Race (NIH/OMB) (Influenza Season 2015-2016)
American Indian or Alaska Native
|
0 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
1 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
1 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Race (NIH/OMB) (Influenza Season 2015-2016)
Asian
|
0 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
1 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
1 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Race (NIH/OMB) (Influenza Season 2015-2016)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
0 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
0 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Race (NIH/OMB) (Influenza Season 2015-2016)
Black or African American
|
22 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
24 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
46 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Race (NIH/OMB) (Influenza Season 2015-2016)
White
|
5 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
5 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
10 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Race (NIH/OMB) (Influenza Season 2015-2016)
More than one race
|
0 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
0 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
0 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Race (NIH/OMB) (Influenza Season 2015-2016)
Unknown or Not Reported
|
0 Participants
n=27 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
0 Participants
n=31 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
0 Participants
n=58 Participants • This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
|
|
Race (NIH/OMB) (Influenza Season 2016-2017)
American Indian or Alaska Native
|
1 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
1 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
2 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
|
Race (NIH/OMB) (Influenza Season 2016-2017)
Asian
|
2 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
0 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
2 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
|
Race (NIH/OMB) (Influenza Season 2016-2017)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
0 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
0 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
|
Race (NIH/OMB) (Influenza Season 2016-2017)
Black or African American
|
38 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
36 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
74 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
|
Race (NIH/OMB) (Influenza Season 2016-2017)
White
|
16 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
24 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
40 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
|
Race (NIH/OMB) (Influenza Season 2016-2017)
More than one race
|
0 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
0 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
0 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
|
Race (NIH/OMB) (Influenza Season 2016-2017)
Unknown or Not Reported
|
0 Participants
n=57 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
3 Participants
n=64 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
3 Participants
n=121 Participants • This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
|
PRIMARY outcome
Timeframe: ED Enrollment Visit through Day 14 ( 2015-2016 influenza season)Population: All subjects enrolled and randomized.
Symptom evaluation during the 2015-2016 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms. Item responses: 1. Not at all 2. A little bit 3. Somewhat 4. Quite a bit 5. Very much
Outcome measures
| Measure |
Oseltamivir
n=27 Participants
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
|
Peramivir
n=31 Participants
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
|
|---|---|---|
|
Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire
Nose
|
1.4 units on a scale
Standard Deviation 0.8
|
1.9 units on a scale
Standard Deviation 1.3
|
|
Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire
Throat
|
1.3 units on a scale
Standard Deviation 0.8
|
1.7 units on a scale
Standard Deviation 1.2
|
|
Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire
Eyes
|
1.2 units on a scale
Standard Deviation 0.6
|
1.6 units on a scale
Standard Deviation 1.2
|
|
Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire
Chest/Respiratory
|
1.9 units on a scale
Standard Deviation 1.2
|
2.3 units on a scale
Standard Deviation 1.5
|
|
Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire
Gastrointestinal
|
1.5 units on a scale
Standard Deviation 1.1
|
1.5 units on a scale
Standard Deviation 1.1
|
|
Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire
Body/Systemic
|
1.7 units on a scale
Standard Deviation 1.2
|
1.9 units on a scale
Standard Deviation 1.4
|
|
Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire
Total/Overall
|
1.6 units on a scale
Standard Deviation 1.1
|
1.9 units on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: ED Enrollment Visit through Day 14 ( 2016-2017 influenza season)Population: All enrolled and randomized subjects with the exception of 1 inadvertent enrollment (subject found to be ineligible shortly after randomization)
Symptom evaluation during the 2016-2017 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms. Item responses: 1. Not at all 2. A little bit 3. Somewhat 4. Quite a bit 5. Very much
Outcome measures
| Measure |
Oseltamivir
n=57 Participants
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
|
Peramivir
n=64 Participants
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
|
|---|---|---|
|
Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire
Nose
|
1.5 units on a scale
Standard Deviation 0.8
|
1.5 units on a scale
Standard Deviation 0.7
|
|
Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire
Throat
|
1.3 units on a scale
Standard Deviation 0.6
|
1.4 units on a scale
Standard Deviation 0.8
|
|
Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire
Eyes
|
1.3 units on a scale
Standard Deviation 0.7
|
1.2 units on a scale
Standard Deviation 0.5
|
|
Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire
Chest/Respiratory
|
1.7 units on a scale
Standard Deviation 0.8
|
1.8 units on a scale
Standard Deviation 0.9
|
|
Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire
Gastrointestinal
|
1.3 units on a scale
Standard Deviation 0.7
|
1.3 units on a scale
Standard Deviation 0.7
|
|
Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire
Body/Systemic
|
1.5 units on a scale
Standard Deviation 0.8
|
1.5 units on a scale
Standard Deviation 0.8
|
|
Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire
Total/Overall
|
1.4 units on a scale
Standard Deviation 0.6
|
1.5 units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: ED Enrollment Visit through Day 14 ( 2015-2016 influenza season)Population: All subjects enrolled and randomized.
The Karnofsky Performance Scale is a tool for assessing subject functional impairment. Subjects provided or received (from a healthcare provider such as a doctor or nurse) a daily rating from 0 (Dead) to 100 (Normal - no complaints, no evidence of disease) from enrollment through Day 14 of the 2015-2016 influenza season.
Outcome measures
| Measure |
Oseltamivir
n=27 Participants
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
|
Peramivir
n=31 Participants
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
|
|---|---|---|
|
Mean Karnofsky Performance Scale Score During the 2015-2016 Influenza Season
|
77.1 units on a scale
Standard Deviation 20.8
|
73.2 units on a scale
Standard Deviation 19.9
|
PRIMARY outcome
Timeframe: ED Enrollment Visit through Day 14 ( 2016-2017 influenza season)Population: All enrolled and randomized subjects with the exception of 1 inadvertent enrollment (subject found to be ineligible shortly after randomization)
The Karnofsky Performance Scale is a tool for assessing subject functional impairment. Subjects provided or received (from a healthcare provider such as a doctor or nurse) a daily rating from 0 (Dead) to 100 (Normal - no complaints, no evidence of disease) from enrollment through Day 14 of the 2016-2017 influenza season.
Outcome measures
| Measure |
Oseltamivir
n=57 Participants
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
|
Peramivir
n=64 Participants
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
|
|---|---|---|
|
Mean Karnofsky Performance Scale Score During the 2016-2017 Influenza Season
|
80.0 units on a scale
Standard Deviation 10.7
|
79.9 units on a scale
Standard Deviation 9.1
|
Adverse Events
Oseltamivir
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Peramivir
Serious events: 9 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oseltamivir
n=84 participants at risk
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
Oseltamivir: Oral
|
Peramivir
n=95 participants at risk
Subjects randomized to the IV treatment group will receive 1 dose (or more as appropriate at the discretion of the treating physician) of IV peramivir.
Peramivir: IV
Note: Should a patient remain in the hospital after 5 days of treatment, and the patient is symptomatically better, treatment will stop. If the patient remains hospitalized after 5 days of treatment and has not improved, the treating physician will continue to have an option to continue use of peramivir daily for another 5 day course.
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal perforation
|
1.2%
1/84 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
0.00%
0/95 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Investigations
Blood creatinine increased
|
1.2%
1/84 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
0.00%
0/95 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
1/84 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
0.00%
0/95 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.2%
1/84 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
0.00%
0/95 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/84 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
1.1%
1/95 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/84 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
1.1%
1/95 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/84 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
1.1%
1/95 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Vascular disorders
Hypotension
|
0.00%
0/84 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
2.1%
2/95 • Number of events 2 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Nervous system disorders
Syncope
|
0.00%
0/84 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
1.1%
1/95 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/84 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
1.1%
1/95 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Musculoskeletal and connective tissue disorders
Abdominal Pain
|
0.00%
0/84 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
1.1%
1/95 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD)
|
0.00%
0/84 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
1.1%
1/95 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Surgical and medical procedures
Pre-op admission
|
0.00%
0/84 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
1.1%
1/95 • Number of events 1 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
Other adverse events
| Measure |
Oseltamivir
n=84 participants at risk
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
Oseltamivir: Oral
|
Peramivir
n=95 participants at risk
Subjects randomized to the IV treatment group will receive 1 dose (or more as appropriate at the discretion of the treating physician) of IV peramivir.
Peramivir: IV
Note: Should a patient remain in the hospital after 5 days of treatment, and the patient is symptomatically better, treatment will stop. If the patient remains hospitalized after 5 days of treatment and has not improved, the treating physician will continue to have an option to continue use of peramivir daily for another 5 day course.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
28/84 • Number of events 32 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
32.6%
31/95 • Number of events 36 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Gastrointestinal disorders
Nausea
|
32.1%
27/84 • Number of events 29 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
22.1%
21/95 • Number of events 23 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Gastrointestinal disorders
Vomiting
|
22.6%
19/84 • Number of events 20 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
16.8%
16/95 • Number of events 17 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Psychiatric disorders
Insomnia
|
14.3%
12/84 • Number of events 14 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
18.9%
18/95 • Number of events 18 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
7/84 • Number of events 8 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
5.3%
5/95 • Number of events 6 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Ear and labyrinth disorders
Vertigo
|
10.7%
9/84 • Number of events 9 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
10.5%
10/95 • Number of events 12 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
|
Nervous system disorders
Confusion/Hallucinations
|
7.1%
6/84 • Number of events 6 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
7.4%
7/95 • Number of events 7 • Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place