Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
NCT ID: NCT00593502
Last Updated: 2009-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
409 participants
INTERVENTIONAL
2008-02-29
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Oseltamivir
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
placebo
The dosage of placebo will be similar to the active drug
Interventions
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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
placebo
The dosage of placebo will be similar to the active drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
3 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Hospital District of Southwestern Finland
OTHER
Responsible Party
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Turku University Hospital, Turku, Finland
Principal Investigators
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Terho J Heikkinen, MD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital, Turku, Finland
Locations
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Turku University Hospital
Turku, , Finland
Countries
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References
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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.
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.
Other Identifiers
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EudraCT 2007-004734-17
Identifier Type: -
Identifier Source: secondary_id
MV21118
Identifier Type: -
Identifier Source: org_study_id
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