NCT01037634

Brief Summary

Currently, there is no standard treatment for influenza with related lower respiratory tract infection (LRTI) in children younger than one year of age, even though influenza related LRTI is a potentially fatal illness in these children. This study will test a medicine for influenza in children younger than one year of age to see if it is safe and effective.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

December 18, 2009

Last Update Submit

August 5, 2014

Conditions

Influenza

Keywords

Avian InfluenzaH1N1 InfluenzaSeasonal Influenza

Outcome Measures

Primary Outcomes (3)

  • Viral clearance of human influenza on a nose and throat swab, assessed by reverse transcriptase polymerase chain reaction (RT PCR)

    Measured on Day 5

  • Viral clearance of H1N1 swine influenza, version found in Vietnam only, on a nose and throat swab, assessed by RT PCR

    Measured on Day 7

  • Viral clearance of avian influenza on a nose and throat swab, assessed by RT PCR

    Measured on Day 10

Secondary Outcomes (17)

  • Time to viral clearance on a throat and nose swab, assessed by RT PCR

    Measured over 14 days

  • The time to no detectable influenza virus by culture for the throat and nose swabs

    Measured over 14 days

  • Change in viral load (by log10 copies/mL) over time for all virological samples, with a lower limit of detection of 1,000 copies/mL

    Measured over 14 days

  • Viral susceptibility of cultured influenza virus to antiviral drugs, assessed by genotypical and phenotypical analyses

    Measured at baseline and post-treatment

  • Time to fever clearance

    Measured over 14 days

  • +12 more secondary outcomes

Study Arms (1)

Oseltamivir

EXPERIMENTAL

Participants will receive Oseltamivir to treat influenza.

Drug: Oseltamivir

Interventions

OseltamivirDRUG

3 mg/kg given orally for 5 days for seasonal influenza, 7 days for 2009 H1N1 influenza (in Vietnam only), or 10 days for avian influenza, for children whose renal function is greater than or equal to 30 mL/min/1.73m2

Also known as: Tamiflu
Oseltamivir

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent signed by a parent or legal guardian
  • Younger than 12 months of age when first seen with a lower respiratory tract infection (LRTI)
  • LRTI must be moderate or severe and influenza must be virologically proven by a respiratory specimen
  • History of fever within 14 days prior to presentation (although fever at presentation is not required) plus any two of the following: cough, difficulty breathing or shortness of breath, increased respiratory rate for current age, intercostal recession, use of accessory muscles, nasal flare or grunting, crepitations with or without wheezing, a consistent abnormal chest x-ray (e.g., new infiltrate, hyperinflation)
  • Virological evidence of influenza on any one of the tests specified in the protocol

You may not qualify if:

  • Known allergy to oseltamivir
  • Illness duration greater than 14 days on the day of hospital admission
  • Creatinine clearance less than 10 mL/min/1.73m2, including a requirement for dialysis or hemofiltration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Broor S, Parveen S, Bharaj P, Prasad VS, Srinivasulu KN, Sumanth KM, Kapoor SK, Fowler K, Sullender WM. A prospective three-year cohort study of the epidemiology and virology of acute respiratory infections of children in rural India. PLoS One. 2007 Jun 6;2(6):e491. doi: 10.1371/journal.pone.0000491.

    PMID: 17551572BACKGROUND

  • American Academy of Pediatrics Committee on Infectious Diseases. Antiviral therapy and prophylaxis for influenza in children. Pediatrics. 2007 Apr;119(4):852-60. doi: 10.1542/peds.2007-0224.

    PMID: 17403862BACKGROUND

  • Ferraris O, Lina B. Mutations of neuraminidase implicated in neuraminidase inhibitors resistance. J Clin Virol. 2008 Jan;41(1):13-9. doi: 10.1016/j.jcv.2007.10.020. Epub 2007 Dec 11.

    PMID: 18055254BACKGROUND

MeSH Terms

Conditions

Influenza, HumanInfluenza in BirdsOrthomyxoviridae Infections

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBird DiseasesAnimal Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Bob Taylor, MD

    Mahidol Oxford University Research

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

December 18, 2009

First Posted

December 23, 2009

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Last Updated

August 6, 2014

Record last verified: 2014-08