Influenza
Conditions
Keywords
influenza, children, acute otitis media, oseltamivir
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.
Interventions
DRUGoseltamivir
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
DRUGplacebo
The dosage of placebo will be similar to the active drug
Sponsors
Hoffmann-La Roche
Hospital District of Southwestern Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication | 1-8 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to resolution of fever and other clinical symptoms | 1-21 days |
Countries
Finland
Outcome results
None listed