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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
oseltamivir
placebo
Sponsored by
Hospital District of Southwestern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza, children, acute otitis media, oseltamivir

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Oseltamivir

Placebo

Outcomes

Primary Outcome Measures

Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication

Secondary Outcome Measures

Time to resolution of fever and other clinical symptoms

Full Information

First Posted
January 4, 2008
Last Updated
June 18, 2009
Sponsor
Hospital District of Southwestern Finland
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00593502
Brief Title
Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
Acronym
ETOPOM
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

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital District of Southwestern Finland
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, children, acute otitis media, oseltamivir

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Oseltamivir
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
oseltamivir
Other Intervention Name(s)
Tamiflu
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
The dosage of placebo will be similar to the active drug
Primary Outcome Measure Information:
Title
Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication
Time Frame
1-8 days
Secondary Outcome Measure Information:
Title
Time to resolution of fever and other clinical symptoms
Time Frame
1-21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terho J Heikkinen, MD
Organizational Affiliation
Turku University Hospital, Turku, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15378427
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.
Results Reference
background
PubMed Identifier
11224828
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. Erratum In: Pediatr Infect Dis J 2001 Apr;20(4):421.
Results Reference
background
PubMed Identifier
21106443
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.
Results Reference
derived
PubMed Identifier
20815736
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.
Results Reference
derived

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

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