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

History of Changes

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:

MedlinePlus related topics: Ear Infections Flu

Drug Information available for: Oseltamivir Oseltamivir phosphate Influenza Vaccines

U.S. FDA Resources

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

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:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Heinonen S, Silvennoinen H, Lehtinen P, Vainionpää R, Ziegler T, Heikkinen T. Effectiveness of inactivated influenza vaccine in children aged 9 months to 3 years: an observational cohort study. Lancet Infect Dis. 2011 Jan;11(1):23-9. Epub 2010 Nov 22.

Heinonen S, Silvennoinen H, Lehtinen P, Vainionpää R, Vahlberg T, Ziegler T, Ikonen N, Puhakka T, Heikkinen T. Early oseltamivir treatment of influenza in children 1-3 years of age: a randomized controlled trial. Clin Infect Dis. 2010 Oct 15;51(8):887-94.

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 June 18, 2013

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