Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

The main purpose of this study is to assess the efficacy of early oseltamivir treatment (started within 24 hours of the onset of influenza symptoms) in preventing the development of acute otitis media as a complication of influenza in children aged 1-3 years.

Inclusion Criteria:

• Age 1-3 years
• Fever = or > 38.0 C and at least one respiratory symptom OR fever = or > 38.0 C and a positive influenza rapid test

Exclusion Criteria:

• Confirmed infection with any other respiratory virus than influenza.
• Suspicion of invasive bacterial infection requiring immediate admission to hospital
• Evidence of a poorly controlled underlying medical condition
• Known immunosuppression (malignancy, transplant, drugs)
• Known allergy to oseltamivir or paracetamol
• Received oseltamivir within 4 weeks
• Participation in another clinical trial with an investigational drug