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Completed

NCT Number: NCT00593502

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.

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Key information

Conditions

Influenza Ear Diseases Infections Influenza, Human Orthomyxoviridae Infections Otitis Otitis Media Otorhinolaryngologic Diseases RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Turku University Hospital

Turku, 20520, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oseltamivir

Drug

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

Other names: Tamiflu

Placebo

Drug

The dosage of placebo will be similar to the active drug

Primary outcomes

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

    Time frame: 1-8 days

Secondary outcomes

  1. Time to resolution of fever and other clinical symptoms

    Time frame: 1-21 days

Sponsors and collaborators

Lead sponsor

Hospital District of Southwestern Finland

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

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

Acronym: ETOPOM

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 15, 2008
Registry last updated
Jun 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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