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

Influenza Clinical Trial

— ETOPOM  

Official title:

A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593502
• Other study ID #: MV21118
• Secondary ID: EudraCT 2007-004
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2008
• Last updated: June 18, 2009
• Start date: February 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Hospital District of Southwestern Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 3 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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
• placebo
The dosage of placebo will be similar to the active drug

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Hospital District of Southwestern Finland	Hoffmann-La Roche

Country where clinical trial is conducted

Finland, 

References & Publications (2)

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. — View 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. Erratum in: Pediatr Infect Dis J 2001 Apr;20(4):421. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication		1-8 days	No
Secondary	Time to resolution of fever and other clinical symptoms		1-21 days	No