COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT00593502
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : June 19, 2009
Hoffmann-La Roche
Information provided by:
Hospital District of Southwestern Finland

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza Drug: oseltamivir Drug: placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
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
Study Start Date : February 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Oseltamivir

Arm Intervention/treatment
Active Comparator: 1
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
Drug: placebo
The dosage of placebo will be similar to the active drug

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00593502

Layout table for location information
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Hospital District of Southwestern Finland
Hoffmann-La Roche
Layout table for investigator information
Principal Investigator: Terho J Heikkinen, MD Turku University Hospital, Turku, Finland
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Terho Heikkinen/Consulting Pediatrician, Assistant Professor, Turku University Hospital, Turku, Finland Identifier: NCT00593502    
Other Study ID Numbers: MV21118
EudraCT 2007-004734-17
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: June 19, 2009
Last Verified: June 2009
Keywords provided by Hospital District of Southwestern Finland:
acute otitis media
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action