Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
Information source: Hospital District of Southwestern Finland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: oseltamivir (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hospital District of Southwestern Finland Official(s) and/or principal investigator(s): Terho J Heikkinen, MD, Principal Investigator, Affiliation: Turku University Hospital, Turku, Finland
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.
Clinical Details
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication
Secondary outcome: Time to resolution of fever and other clinical symptoms
Eligibility
Minimum age: 1 Year.
Maximum age: 3 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Turku University Hospital, Turku 20520, Finland
Additional Information
Related publications: 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. 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.
Starting date: February 2008
Last updated: June 18, 2009
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