Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza
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|ClinicalTrials.gov Identifier: NCT00453999|
Recruitment Status : Completed
First Posted : March 29, 2007
Results First Posted : February 12, 2015
Last Update Posted : February 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Drug: Peramivir 200 mg Drug: Peramivir 400 mg Drug: Oseltamivir||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II, Multicenter, Randomized, Double-Mask, Double-Dummy Study Comparing Efficacy and Safety of Intravenous Peramivir Once Daily Versus Oral Oseltamivir Twice Daily in Adults With Acute Serious or Potentially Life-Threatening Influenza|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||August 2009|
Experimental: Arm 1: Peramivir 200 mg
Peramivir 200 mg administered intravenously once daily for 5 days (5 doses)
Drug: Peramivir 200 mg
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
Experimental: Arm 2: Peramivir 400 mg
Peramivir 400 mg administered intravenously once daily for 5 days (5 doses)
Drug: Peramivir 400 mg
Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml)
Experimental: Arm 3: Oseltamivir
Oseltamivir 75 mg oral suspension administered orally twice daily for 5 days (10 doses)
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
- Time to Clinical Stability (Kaplan-Meier Estimate) [ Time Frame: 14 days ]Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).
- Change From Baseline in Scores of Symptoms of Influenza [ Time Frame: Baseline, Days 2, 3, 4, 5, 10, and 14 ]Descriptive statistics for the change from baseline in each of the 7 symptoms of influenza (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue, each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]) were tabulated by treatment group. Missing data were excluded.
- Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate) [ Time Frame: 14 days ]Changes in each subject's ability to perform usual activities as determined from the visual analog scale (0 to 10, where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully) were summarized by study visit and treatment group. The time to resumption of a subject's ability to perform usual activities was estimated using the method of Kaplan Meier. Subjects who did not return to the pre-study level of performance of usual activities were censored at the time of their last assessment. (Note: N is the number of ITTI participants with available data).
- Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study) [ Time Frame: 14 days ]The number of subjects with clinical relapse, defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours after clinical stability had been attained, were summarized by treatment group.
- Time to Hospital Discharge (Kaplan-Meier Estimate) [ Time Frame: 14 days ]Time to discharge from hospital was estimated using the method of Kaplan Meier. Subjects who were not discharged from the hospital were censored at the time of their last assessment.
- Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) [ Time Frame: Baseline, and 12, 24, 36, 48, 72, and 96 hours ]Reduction in viral shedding, assessed as the change in quantitative viral titers and defined as the time-weighted change from baseline in TCID50/mL, was summarized for each treatment group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453999
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