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Oseltamivir for Influenza Lower Respiratory Tract Infection in Children Under One

NCT01546935 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2013-07-29

No results posted yet for this study

Summary

Currently, there is no treatment for children less than one year of age with influenza related lower respiratory tract infection that is either considered standard or registered in any country. This dismal scenario exists even though influenza related LRTI is a significant illness causing morbidity and mortality, especially in children less than 6 months of age. Avian influenza has been reported rarely in children less than one.

There are no data in Vietnam and very few data in Thailand on the burden of influenza in children less than one. This young age group suffers high mortality. Oseltamivir may be beneficial in such children. This is basis of this trial.

Conditions

Interventions

DRUG

Oseltamivir

The dose of Oseltamivir will be 3 mg/kg 12 hourly for 5 days (seasonal influenza and 2009 H1N1) or 10 days (avian influenza) for children whose renal function is ≥ 30 mls/min/1.73m2.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Kulkanya Chokephaibulkit, MD · Siriraj Hospital

  • Piyarat Suntarattiwong, MD · Queen Sirikit National Institute of Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01546935 on ClinicalTrials.gov