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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593502
First Posted: January 15, 2008
Last Update Posted: June 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by:
Hospital District of Southwestern Finland
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Time to resolution of fever and other clinical symptoms [ Time Frame: 1-21 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: January 4, 2008
First Posted: January 15, 2008
Last Update Posted: June 19, 2009
Last Verified: June 2009

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action