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

Hospital District of Southwestern Finland

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Drug: placebo; Drug: oseltamivir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00593502

EudraCT 2007-004734-17

MV21118

Details and patient eligibility

About

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.

Enrollment: 409 patients

Sex: All

Ages: 1 to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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409 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Oseltamivir

Treatment:

Drug: oseltamivir

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo