Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
- Registration Number
- NCT00593502
- Lead Sponsor
- Hospital District of Southwestern Finland
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 409
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 oseltamivir Oseltamivir 2 placebo Placebo
- Primary Outcome Measures
Name Time Method Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication 1-8 days
- Secondary Outcome Measures
Name Time Method Time to resolution of fever and other clinical symptoms 1-21 days
Trial Locations
- Locations (1)
Turku University Hospital
🇫🇮Turku, Finland