Clinical trial NCT00593502: Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: influenza
children
acute otitis media
oseltamivir
Lead sponsor: Hospital District of Southwestern Finland
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2008-01-15
Enrollment: 409
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication
timeFrame: 1-8 days
Secondary outcomes:
measure: Time to resolution of fever and other clinical symptoms
timeFrame: 1-21 days
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital, Turku, Finland
name: Terho J Heikkinen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.