Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age (ETOPOM)

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Hospital District of Southwestern Finland
ClinicalTrials.gov Identifier:
NCT00593502
First received: January 4, 2008
Last updated: June 18, 2009
Last verified: June 2009

January 4, 2008
June 18, 2009
February 2008
June 2009   (final data collection date for primary outcome measure)
Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication [ Time Frame: 1-8 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00593502 on ClinicalTrials.gov Archive Site
Time to resolution of fever and other clinical symptoms [ Time Frame: 1-21 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Drug: oseltamivir
    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
    Other Name: Tamiflu
  • Drug: placebo
    The dosage of placebo will be similar to the active drug
  • Active Comparator: 1
    Oseltamivir
    Intervention: Drug: oseltamivir
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
409
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
1 Year to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00593502
MV21118, EudraCT 2007-004734-17
Yes
Terho Heikkinen/Consulting Pediatrician, Assistant Professor, Turku University Hospital, Turku, Finland
Hospital District of Southwestern Finland
Hoffmann-La Roche
Principal Investigator: Terho J Heikkinen, MD Turku University Hospital, Turku, Finland
Hospital District of Southwestern Finland
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP