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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


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


Minimum age: 1 Year. Maximum age: 3 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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