Influenza Clinical Trial
— ETOPOMOfficial title:
A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
Verified date | June 2009 |
Source | Hospital District of Southwestern Finland |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Finnish Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 409 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 3 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Hospital District of Southwestern Finland | Hoffmann-La Roche |
Finland,
Heikkinen T, Silvennoinen H, Peltola V, Ziegler T, Vainionpaa R, Vuorinen T, Kainulainen L, Puhakka T, Jartti T, Toikka P, Lehtinen P, Routi T, Juven T. Burden of influenza in children in the community. J Infect Dis. 2004 Oct 15;190(8):1369-73. Epub 2004 Sep 15. — View Citation
Whitley RJ, Hayden FG, Reisinger KS, Young N, Dutkowski R, Ipe D, Mills RG, Ward P. Oral oseltamivir treatment of influenza in children. Pediatr Infect Dis J. 2001 Feb;20(2):127-33. Erratum in: Pediatr Infect Dis J 2001 Apr;20(4):421. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication | 1-8 days | No | |
Secondary | Time to resolution of fever and other clinical symptoms | 1-21 days | No |
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