NCT00593502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
409

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 19, 2009

Status Verified

June 1, 2009

Enrollment Period

1.3 years

First QC Date

January 4, 2008

Last Update Submit

June 18, 2009

Conditions

Influenza

Keywords

influenzachildrenacute otitis mediaoseltamivir

Outcome Measures

Primary Outcomes (1)

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

    1-8 days

Secondary Outcomes (1)

  • Time to resolution of fever and other clinical symptoms

    1-21 days

Study Arms (2)

1

ACTIVE COMPARATOR

Oseltamivir

Drug: oseltamivir

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

oseltamivirDRUG

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

Also known as: Tamiflu
1
placeboDRUG

The dosage of placebo will be similar to the active drug

2

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (4)

  • 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.

    PMID: 15378427BACKGROUND

  • 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.

    PMID: 11224828BACKGROUND

  • 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.

    PMID: 21106443DERIVED

  • 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.

    PMID: 20815736DERIVED

MeSH Terms

Conditions

Influenza, HumanOtitis Media

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Terho J Heikkinen, MD

    Turku University Hospital, Turku, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 15, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 19, 2009

Record last verified: 2009-06

Locations

FI(1)