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A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza

NCT00949533 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-08-08

Study results available
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Summary

This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (\</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams \[mg\] orally twice daily \[bid\]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (\>) 100.

Conditions

Interventions

DRUG

Oseltamivir

Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

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 NCT00949533 on ClinicalTrials.gov