Seasonal Influenza, Cough, Sore Throat, Nasal Congestion, Myalgia, Headache, Fatigue
Conditions
Keywords
influenza, hospitalized, flu, antiviral
Brief summary
This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected influenza infection.
Interventions
DRUGPeramivir
300 mg twice daily
Sponsors
Department of Health and Human Services
BioCryst Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and non-pregnant female subjects 6 years of age or older. * Able to provide written informed consent, or for whom written consent may be provided by a parent guardian or legally authorized representative, unless consent provided by a parent, guardian or legally authorized representative is not consistent with applicable local or ethical procedures, directives and /or guidelines. * Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection; a measured temperature of ≥ 38.0°C (100.4°F) oral, or ≥ 38.6°C (101.4°F) rectal or tympanic and recent onset of at least one of the following: rhinorrhea or nasal congestion, sore throat or cough. Measured temperature can include fever meeting the above criteria as reported by the subject or their parent, guardian or legally authorized representative in the 24 hours prior to Screening. The requirement for fever is waived for any subject with influenza infection already confirmed by laboratory tests (including Rapid Antigen Tests). * Confirmation of influenza A or B infection in the local community by one of the following means: * the institution's local laboratory, * the local public health system * the national public health system * a laboratory of a recognized national or multinational influenza surveillance scheme. * Severity of illness requiring or anticipated to require in-hospital care.
Exclusion criteria
* Subjects who have been hospitalized for greater than 24 hours (not including time spent in the emergency department).Blood platelet count of \< 20 x 109/L. * Serum bilirubin \> 6 mg/dL at time of Screening evaluation. * Serum ALT or AST \> 5 X upper limit of normal at time of Screening evaluation. * Serum creatinine \> 5.0 mg/dL at time of Screening evaluation. * Subjects who require peritoneal dialysis or hemofiltration. * Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically induced. * Females who are pregnant (positive urine or serum pregnancy test at Screening evaluation) or breastfeeding. * Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. (Subjects who have completed treatment 30 days prior to enrollment are allowed to enroll in the study. Hormone treatment for cancer is also acceptable). * Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months. * HIV infection with a known CD4 count \< 200 cells/ mm3 unless on a stable highly active antiretroviral (HAART) regimen for at least 6 months. * Presence of a preexisting chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). (Subjects with chronic osteomyelitis or hepatitis B or C not requiring treatment are not excluded). * Presence of any preexisting illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study. * Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the Screening evaluation. * Subjects diagnosed with cystic fibrosis. * Subjects with confirmed clinical evidence of acute non-influenzal infection at the time of Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Influenza Virus Titer (48 Hours) | Baseline and 48 hours | The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL) | Baseline, 48, 108, 216 hours | The time-weighted change from baseline in viral titer measured by RT-PCR was calculated on a by-subject basis through 216 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group. |
| Time to Clinical Resolution | 28 days | Time to clinical resolution was the number of hours from initiation of study treatment until 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) met resolution criteria that was maintained for at least 24 hours. The median time to clinical resolution and associated 95% confidence interval were estimated for each treatment group using the method of Kaplan-Meier. Subjects who did not achieve clinical resolution were censored at the time of their last assessment. |
| Number of Participants With Clinical Resolution | 28 days | Clinical resolution was defined as normalization of at least 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) for at least 24 hours. |
| Time to Alleviation of Symptoms | 28 days | Time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 24 hour period where all seven symptoms of influenza are recorded as none or mild, was estimated using the method of Kaplan-Meier (adolescents and adults). The 95% confidence interval about the median was presented. Subjects who did not experience alleviation of symptoms were censored at the time of the last non-missing symptom assessment. |
| Time to Resolution of Fever | 28 days | Time to resolution of fever was the number of hours from initiation of study treatment until temperature was ≤37.2°C/≤99°F oral or ≤37.8°C/≤100°F rectal or tympanic for at least 24 hours with no antipyretic medication taken within 4 hours prior to the temperature measurement. Subjects who did not achieve resolution of fever were censored at the time of their last assessment. The 95% confidence interval about the median were presented. |
| Time to Hospital Discharge | 28 days | Time to hospital discharge, defined as the number of days from initiation of study drug until the subject is discharged from the hospital, was estimated using the method of Kaplan-Meier. The 95% confidence interval about the median was presented. Subjects who were not discharged during the study period were censored at the last study visit. Subjects who died prior to discharge were censored at the longest observed time to discharge. |
| Number of Participants Experiencing Influenza-related Complications | 28 days | Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis and pneumonia as reported on the Influenza-related complications CRF. |
| Number of Participants Admitted to ICU After Initiation of Treatment | 28 days | The number of subjects experiencing ICU admission after initiation of treatment. |
| Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate) | 28 days | The duration of ICU admission after initiation of treatment was estimated by the method of Kaplan-Meier. Subjects who were not discharged from the ICU were censored at the time of their last assessment |
| Survival (Kaplan-Meier Estimates) | 14 and 28 days | Survival was calculated as the number of days from initiation of study drug until death or last contact. Overall survival was estimated by the method of Kaplan-Meier; 95% confidence intervals for 14- and 28-day survival were presented by treatment group. Subjects who had not died were censored at the date of last contact. |
| Time to Resumption of Usual Activities | 28 days | Subject's ability to perform usual activities as determined from the visual analog scale (scale ranges from 0 to 10 where 0 indicates subject was unable to perform usual activities at all and 10 indicates subject is able to perform all usual activities fully) was summarized by study visit day and treatment group. The median time to resumption of usual daily activities and associated 95% CI was estimated using the method of Kaplan-Meier for adults and adolescents. Subjects who did not return to the pre-study level of performance of usual daily activities were censored at the time of their last non-missing visual analog scale value. A separate analysis was conducted for children. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Required More Than 5 Days of Peramivir Treatment | 28 days | The number of subjects who continued more than 5 days were as reported on the Continuation of Treatment CRF page. |
Countries
Australia, Canada, Mexico, New Zealand, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peramivir 300mg 300 mg twice daily
Peramivir: 300 mg twice daily | 117 |
| Peramivir 600mg 600 mg once daily
Peramivir: 600 mg once daily | 117 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 4 | 10 |
| Overall Study | Influenza-related complication | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Missing | 1 | 0 |
| Overall Study | Noncompliance; Protocol Deviations | 5 | 6 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 2 |
Baseline characteristics
| Characteristic | Peramivir 600mg | Peramivir 300mg | Total |
|---|---|---|---|
| Age, Continuous | 48.4 years | 48.3 years | 48.3 years |
| Age, Customized Adolescents 12-17 years | 1 participants | 3 participants | 4 participants |
| Age, Customized Adults 18-24 years | 8 participants | 4 participants | 12 participants |
| Age, Customized Adults 25-34 years | 19 participants | 17 participants | 36 participants |
| Age, Customized Adults 35-44 years | 18 participants | 29 participants | 47 participants |
| Age, Customized Adults 45-54 years | 29 participants | 26 participants | 55 participants |
| Age, Customized Adults 55-64 years | 27 participants | 18 participants | 45 participants |
| Age, Customized Adults 65-74 years | 10 participants | 11 participants | 21 participants |
| Age, Customized Adults ≥75 years | 5 participants | 9 participants | 14 participants |
| Age, Customized Children 6-11 years | 0 participants | 0 participants | 0 participants |
| APACHE II Score | 17 units on a scale STANDARD_DEVIATION 5.4 | 14 units on a scale STANDARD_DEVIATION 7.5 | 15 units on a scale STANDARD_DEVIATION 6.6 |
| Body mass index (BMI) | 31 kg/m^2 | 32 kg/m^2 | 31 kg/m^2 |
| Chest X-ray at Screening Abnormal | 28 participants | 31 participants | 59 participants |
| Chest X-ray at Screening Missing | 3 participants | 4 participants | 7 participants |
| Chest X-ray at Screening Normal | 86 participants | 82 participants | 168 participants |
| Corticosteroid at enrollment No | 49 participants | 65 participants | 114 participants |
| Corticosteroid at enrollment Yes | 68 participants | 52 participants | 120 participants |
| Duration of hospital admission prior to first dose | 1.3 days STANDARD_DEVIATION 2.86 | 1.1 days STANDARD_DEVIATION 0.98 | 1.2 days STANDARD_DEVIATION 2.13 |
| Duration of illness ≤48 hours | 16 participants | 18 participants | 34 participants |
| Duration of illness >48 hours | 101 participants | 99 participants | 200 participants |
| Hemisphere of enrollment Northern Hemisphere 09-10 | 108 participants | 107 participants | 215 participants |
| Hemisphere of enrollment Southern Hemisphere 10 | 9 participants | 10 participants | 19 participants |
| Influenza vaccination status Missing | 0 participants | 2 participants | 2 participants |
| Influenza vaccination status Not vaccinated this year | 81 participants | 74 participants | 155 participants |
| Influenza vaccination status Vaccinated this year | 36 participants | 41 participants | 77 participants |
| Moderate renal impairment Impaired | 11 participants | 10 participants | 21 participants |
| Moderate renal impairment Missing | 1 participants | 4 participants | 5 participants |
| Moderate renal impairment Not impaired | 105 participants | 103 participants | 208 participants |
| Number of subjects with ICU admission at Baseline | 21 participants | 18 participants | 39 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Asian | 5 participants | 5 participants | 10 participants |
| Race/Ethnicity, Customized Black, of African Heritage or African American | 13 participants | 16 participants | 29 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Other | 11 participants | 15 participants | 26 participants |
| Race/Ethnicity, Customized White | 84 participants | 78 participants | 162 participants |
| Screening lymphocytes Grade 3/4 | 22 participants | 15 participants | 37 participants |
| Screening lymphocytes Missing | 6 participants | 13 participants | 19 participants |
| Screening lymphocytes Other Grade | 89 participants | 89 participants | 178 participants |
| Screening neutrophils Grade 3/4 | 3 participants | 0 participants | 3 participants |
| Screening neutrophils Missing | 6 participants | 13 participants | 19 participants |
| Screening neutrophils Other Grade | 108 participants | 104 participants | 212 participants |
| Screening serum albumin Grade 3 | 8 participants | 6 participants | 14 participants |
| Screening serum albumin Missing | 6 participants | 6 participants | 12 participants |
| Screening serum albumin Other Grade | 103 participants | 105 participants | 208 participants |
| Sex: Female, Male Female | 65 Participants | 74 Participants | 139 Participants |
| Sex: Female, Male Male | 52 Participants | 43 Participants | 95 Participants |
| Smoking status Current smoker | 45 participants | 43 participants | 88 participants |
| Smoking status Missing | 0 participants | 1 participants | 1 participants |
| Smoking status Not current smoker | 72 participants | 73 participants | 145 participants |
| Subjects who received antivirals prior to treatment | 82 participants | 88 participants | 170 participants |
| Supplemental oxygen required at Screening Missing | 2 participants | 1 participants | 3 participants |
| Supplemental oxygen required at Screening No | 32 participants | 41 participants | 73 participants |
| Supplemental oxygen required at Screening Yes | 83 participants | 75 participants | 158 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 69 / 114 | 65 / 116 |
| serious Total, serious adverse events | 21 / 114 | 26 / 116 |
Outcome results
Primary
Change From Baseline in Influenza Virus Titer (48 Hours)
The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.
Time frame: Baseline and 48 hours
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 83 subjects were excluded due to negative Baseline titers (log10 TCID50 0.5).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peramivir 300 mg | Change From Baseline in Influenza Virus Titer (48 Hours) | -1.66 log10 TCID50/mL |
| Peramivir 600 mg | Change From Baseline in Influenza Virus Titer (48 Hours) | -1.47 log10 TCID50/mL |
Secondary
Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)
The time-weighted change from baseline in viral titer measured by RT-PCR was calculated on a by-subject basis through 216 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.
Time frame: Baseline, 48, 108, 216 hours
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 41 subjects were excluded due to negative Baseline titers (viral particles/mL RT-PCR value 1.58 for Influenza A and 1.49 for Influenza B).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Peramivir 300 mg | Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL) | Change from baseline, 48 hours | -1.00 log10 viral particles/mL |
| Peramivir 300 mg | Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL) | Change from baseline, 108 hours | -1.65 log10 viral particles/mL |
| Peramivir 300 mg | Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL) | Change from baseline, 216 hours | -2.15 log10 viral particles/mL |
| Peramivir 600 mg | Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL) | Change from baseline, 48 hours | -1.07 log10 viral particles/mL |
| Peramivir 600 mg | Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL) | Change from baseline, 108 hours | -1.59 log10 viral particles/mL |
| Peramivir 600 mg | Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL) | Change from baseline, 216 hours | -1.79 log10 viral particles/mL |
Secondary
Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate)
The duration of ICU admission after initiation of treatment was estimated by the method of Kaplan-Meier. Subjects who were not discharged from the ICU were censored at the time of their last assessment
Time frame: 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peramivir 300 mg | Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate) | 7 days |
| Peramivir 600 mg | Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate) | 7 days |
Secondary
Number of Participants Admitted to ICU After Initiation of Treatment
The number of subjects experiencing ICU admission after initiation of treatment.
Time frame: 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peramivir 300 mg | Number of Participants Admitted to ICU After Initiation of Treatment | 2 participants |
| Peramivir 600 mg | Number of Participants Admitted to ICU After Initiation of Treatment | 6 participants |
Secondary
Number of Participants Experiencing Influenza-related Complications
Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis and pneumonia as reported on the Influenza-related complications CRF.
Time frame: 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peramivir 300 mg | Number of Participants Experiencing Influenza-related Complications | 39 participants |
| Peramivir 600 mg | Number of Participants Experiencing Influenza-related Complications | 48 participants |
Secondary
Number of Participants With Clinical Resolution
Clinical resolution was defined as normalization of at least 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) for at least 24 hours.
Time frame: 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peramivir 300 mg | Number of Participants With Clinical Resolution | 41 participants |
| Peramivir 600 mg | Number of Participants With Clinical Resolution | 42 participants |
Secondary
Survival (Kaplan-Meier Estimates)
Survival was calculated as the number of days from initiation of study drug until death or last contact. Overall survival was estimated by the method of Kaplan-Meier; 95% confidence intervals for 14- and 28-day survival were presented by treatment group. Subjects who had not died were censored at the date of last contact.
Time frame: 14 and 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peramivir 300 mg | Survival (Kaplan-Meier Estimates) | 14 Day Survival | 98 Percent Survival |
| Peramivir 300 mg | Survival (Kaplan-Meier Estimates) | 28 Day Survival | 94 Percent Survival |
| Peramivir 600 mg | Survival (Kaplan-Meier Estimates) | 14 Day Survival | 93 Percent Survival |
| Peramivir 600 mg | Survival (Kaplan-Meier Estimates) | 28 Day Survival | 86 Percent Survival |
Secondary
Time to Alleviation of Symptoms
Time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 24 hour period where all seven symptoms of influenza are recorded as none or mild, was estimated using the method of Kaplan-Meier (adolescents and adults). The 95% confidence interval about the median was presented. Subjects who did not experience alleviation of symptoms were censored at the time of the last non-missing symptom assessment.
Time frame: 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Symptom data for 18 subjects was missing.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peramivir 300 mg | Time to Alleviation of Symptoms | 135 hours |
| Peramivir 600 mg | Time to Alleviation of Symptoms | 158 hours |
Secondary
Time to Clinical Resolution
Time to clinical resolution was the number of hours from initiation of study treatment until 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) met resolution criteria that was maintained for at least 24 hours. The median time to clinical resolution and associated 95% confidence interval were estimated for each treatment group using the method of Kaplan-Meier. Subjects who did not achieve clinical resolution were censored at the time of their last assessment.
Time frame: 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peramivir 300 mg | Time to Clinical Resolution | 44.7 hours |
| Peramivir 600 mg | Time to Clinical Resolution | 166.1 hours |
Secondary
Time to Hospital Discharge
Time to hospital discharge, defined as the number of days from initiation of study drug until the subject is discharged from the hospital, was estimated using the method of Kaplan-Meier. The 95% confidence interval about the median was presented. Subjects who were not discharged during the study period were censored at the last study visit. Subjects who died prior to discharge were censored at the longest observed time to discharge.
Time frame: 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peramivir 300 mg | Time to Hospital Discharge | 6 days |
| Peramivir 600 mg | Time to Hospital Discharge | 6 days |
Secondary
Time to Resolution of Fever
Time to resolution of fever was the number of hours from initiation of study treatment until temperature was ≤37.2°C/≤99°F oral or ≤37.8°C/≤100°F rectal or tympanic for at least 24 hours with no antipyretic medication taken within 4 hours prior to the temperature measurement. Subjects who did not achieve resolution of fever were censored at the time of their last assessment. The 95% confidence interval about the median were presented.
Time frame: 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peramivir 300 mg | Time to Resolution of Fever | 27.2 hours |
| Peramivir 600 mg | Time to Resolution of Fever | 24.2 hours |
Secondary
Time to Resumption of Usual Activities
Subject's ability to perform usual activities as determined from the visual analog scale (scale ranges from 0 to 10 where 0 indicates subject was unable to perform usual activities at all and 10 indicates subject is able to perform all usual activities fully) was summarized by study visit day and treatment group. The median time to resumption of usual daily activities and associated 95% CI was estimated using the method of Kaplan-Meier for adults and adolescents. Subjects who did not return to the pre-study level of performance of usual daily activities were censored at the time of their last non-missing visual analog scale value. A separate analysis was conducted for children.
Time frame: 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peramivir 300 mg | Time to Resumption of Usual Activities | 27.7 hours |
| Peramivir 600 mg | Time to Resumption of Usual Activities | 24.9 hours |
Other Pre-specified
Number of Participants Who Required More Than 5 Days of Peramivir Treatment
The number of subjects who continued more than 5 days were as reported on the Continuation of Treatment CRF page.
Time frame: 28 days
Population: The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peramivir 300 mg | Number of Participants Who Required More Than 5 Days of Peramivir Treatment | 16 participants |
| Peramivir 600 mg | Number of Participants Who Required More Than 5 Days of Peramivir Treatment | 28 participants |