- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593502
Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age (ETOPOM)
June 18, 2009 updated by: Hospital District of Southwestern Finland
A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
409
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Turku, Finland, 20520
- Turku University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
The dosage of placebo will be similar to the active drug
|
Active Comparator: 1
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication
Time Frame: 1-8 days
|
1-8 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to resolution of fever and other clinical symptoms
Time Frame: 1-21 days
|
1-21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Terho J Heikkinen, MD, Turku University Hospital, Turku, Finland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1086/424527. 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. doi: 10.1097/00006454-200102000-00002. Erratum In: Pediatr Infect Dis J 2001 Apr;20(4):421.
- Heinonen S, Silvennoinen H, Lehtinen P, Vainionpaa 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. doi: 10.1016/S1473-3099(10)70255-3. Epub 2010 Nov 22.
- Heinonen S, Silvennoinen H, Lehtinen P, Vainionpaa 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. doi: 10.1086/656408.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
January 4, 2008
First Submitted That Met QC Criteria
January 14, 2008
First Posted (Estimate)
January 15, 2008
Study Record Updates
Last Update Posted (Estimate)
June 19, 2009
Last Update Submitted That Met QC Criteria
June 18, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MV21118
- EudraCT 2007-004734-17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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