Conditions: Influenza
Keywords: influenza flu
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 137
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Peramivir 200 mg administered intravenously once daily for 5 days (5 doses) arm 2: Peramivir 400 mg administered intravenously once daily for 5 days (5 doses) arm 3: Oseltamivir 75 mg oral suspension administered orally twice daily for 5 days (10 doses)

Interventions: intervention 1: Peramivir 200 mg intervention 2: Peramivir 400 mg intervention 3: Oseltamivir
Intervention descriptions: intervention 1: Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment intervention 2: Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml) intervention 3: Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)

Protocol document: