Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age - Full Text View

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

This study is currently recruiting participants.

Verified by Hospital District of Southwestern Finland, December 2008

First Received: January 4, 2008 Last Updated: December 30, 2008 History of Changes

Sponsors and Collaborators:	Hospital District of Southwestern Finland Hoffmann-La Roche
Information provided by:	Hospital District of Southwestern Finland
ClinicalTrials.gov Identifier:	NCT00593502

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 IV

MedlinePlus related topics: Ear Infections Flu

Drug Information available for: Oseltamivir Tamiflu

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	300
Study Start Date:	February 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Placebo Comparator 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

Contacts

Contact: Terho J Heikkinen, MD

+358-2-313-2434

terho.heikkinen@utu.fi

Locations

Finland
Turku University Hospital	Recruiting
Turku, Finland, 20520
Contact: Terho J Heikkinen, MD +358-2-313-2434 terho.heikkinen@utu.fi
Principal Investigator: Terho J Heikkinen, MD
Sub-Investigator: Heli Silvennoinen, MD
Sub-Investigator: Santtu Heinonen, MD
Sub-Investigator: Pasi Lehtinen, MD

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.

Responsible Party:	Turku University Hospital, Turku, Finland ( Terho Heikkinen/Consulting Pediatrician, Assistant Professor )
Study ID Numbers:	MV21118, EudraCT 2007-004734-17
Study First Received:	January 4, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00593502 History of Changes
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Hospital District of Southwestern Finland:

influenza
children
acute otitis media
oseltamivir

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otitis
Otitis Media

Influenza, Human
Orthomyxoviridae Infections
Antiviral Agents
Oseltamivir

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Orthomyxoviridae Infections
Antiviral Agents
Pharmacologic Actions

Oseltamivir
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Influenza, Human

ClinicalTrials.gov processed this record on May 07, 2009