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
  Purpose

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.


Condition Intervention Phase
Influenza
Drug: oseltamivir
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

Resource links provided by NLM:


Further study details as provided by Hospital District of Southwestern Finland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Time to resolution of fever and other clinical symptoms [ Time Frame: 1-21 days ] [ Designated as safety issue: No ]

Enrollment: 409
Study Start Date: February 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Oseltamivir
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
Placebo Comparator: 2
Placebo
Drug: placebo
The dosage of placebo will be similar to the active drug

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593502

Locations
Finland
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Hospital District of Southwestern Finland
Hoffmann-La Roche
Investigators
Principal Investigator: Terho J Heikkinen, MD Turku University Hospital, Turku, Finland
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Terho Heikkinen/Consulting Pediatrician, Assistant Professor, Turku University Hospital, Turku, Finland
ClinicalTrials.gov Identifier: NCT00593502     History of Changes
Other Study ID Numbers: MV21118, EudraCT 2007-004734-17
Study First Received: January 4, 2008
Last Updated: June 18, 2009
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Hospital District of Southwestern Finland:
influenza
children
acute otitis media
oseltamivir

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014