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

Hospital District of Southwestern Finland409 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

409

Conditions

Influenza

Interventions

oseltamivirDRUG

Body weight: ≤ 15 kg, 30 mg twice daily; 15 - ≤ 23 kg, 45 mg twice daily; 23 - ≤ 40 kg, 60 mg twice daily; \> 40 kg, 75 mg twice daily, for 5 days

placeboDRUG

The dosage of placebo will be similar to the active drug

Eligibility

Sex: ALLMin age: 1 YearMax age: 3 Years

Medical Language ↔ Plain English

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

Locations (1)

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication

Time frame: 1-8 days

Secondary Outcomes

Time to resolution of fever and other clinical symptoms

Time frame: 1-21 days

Data from ClinicalTrials.gov

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