Efficacy Study of Early Versus Late Oseltamivir Administration for Treating and Preventing Influenza
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
This study is a randomized, blinded, placebo-controlled clinical efficacy trial to assess the
duration and severity of influenza symptoms, and duration of viral shedding, in influenza
patients receiving oseltamivir early and late relative to placebo.
There are two main hypotheses in this study:
1. The duration of influenza symptoms, mean severity score, and duration of viral shedding
are reduced in patients who initiate oseltamivir treatment late (48 to 119 hours)
compared to those receiving no antiviral therapy.
2. Prior influenza vaccination (same season) reduces the duration of influenza symptoms and
mean symptom severity in patients receiving oseltamivir after adjusting for age and
timing of antiviral therapy (early versus late).
There are two secondary hypotheses:
1. The duration of influenza symptoms, mean severity score, and duration of viral shedding
are reduced in patients with influenza who initiate oseltamivir treatment early (< 48
hours) versus late (48 to 119 hours).
2. The incidence of secondary complications is lower in patients initiating oseltamivir
therapy late relative to those receiving no antiviral therapy.