At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Fever ≥38.0°C oral (or ≥38.5°C rectal) at screening, or history of fever within 24 hours with antipyretic use, or feverishness in prior 48 hours
- ✓At least 1 respiratory symptom (cough, sore throat, or nasal congestion) of any severity
- ✓At least 1 constitutional symptom (headache, myalgia, feverishness, malaise, or fatigue) of any severity
- ✕Live attenuated influenza vaccine within previous weeks
- ✕Prior treatment with rimantadine, amantadine, zanamivir, or oseltamivir within 7 days
- ✕Current clinical evidence of acute non-influenzal infection with onset prior to screening
- ✕Serum creatinine >1.6 mg/dL or >25% above upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Peramivir 200 mg, Peramivir 400 mg, and 1 other intervention for Influenza. Completed, enrolled 137 participants across 83 sites in 7 countries.
Detailed Summary
This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.
Study Details
Timeline
Interventions
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml)
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)