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Oseltamivir Randomised Controlled Efficacy Trial

NCT00707941 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1190

Last updated 2018-06-06

No results posted yet for this study

Summary

Background In preparation for a global influenza pandemic, there is an urgent need for representative data from populations and settings where the pandemic is most likely to arise. There are no data on oseltamivir efficacy from Asian urban slum populations concerning duration of illness and viral shedding, nor whether efficacy depends on starting treatment \< 48 hours or ≥ 48 hours after illness onset. Finally, there are no data on the capacity of the drug, in such settings, to affect household and community transmission rates.

Aims and Objectives This proposal aims to compare the duration of clinical illness among patients treated with oseltamivir vs placebo \< 48 hours and ≥ 48 hours after illness onset. It will compare the duration of viral shedding among all treatment groups vs placebo, risk of transmission to household contacts by treatment group and whether neuraminidase inhibitor use creates resistance. Secondarily it aims to measure the effect on influenza.

Design and Methods A double-blind placebo controlled clinical trial design among a population in an urban slum under current influenza disease burden surveillance will be enrolled. Infection status will be confirmed by rRT-PCR. Patients ≥ 1 year old will be randomised to \< 48 hour and ≥ 48 hour treatment arms. Family members and neighbours will also be assessed by PCR and a basic reproductive number calculated (R0).

Relevance These findings will address whether oseltamivir can affect illness duration and severity, affect transmission, incidence and resistance in high risk urban Asian settings where a pandemic is most likely to arise.

Conditions

Interventions

DRUG

Oseltamivir

Children ≤12 years: Suspension by Weight (Kg) as follows: Dose X 5 days Volume (ml) \< 15kg = 30 mg PO BID (2.5 ml) 15kg - 22kg = 45 mg PO BID (3.75 ml) 23kg - 39kg = 60 mg PO BID (5 ml) Patients≥12 years: 75 mg capsules as follows: 1 cap (75 mg) PO BID X 5 days ≥ 40 75 mg PO BID 6.25

DRUG

Placebo

Children \< 12 years, suspension by weight (kg) as follows: Dose X 5 days Volume (ml) \< 15kg = 30 mg PO BID (2.5 ml) 15kg - 22kg = 45 mg PO BID (3.75 ml) 23kg - 39kg = 60 mg PO BID (5 ml) Patients≥12 years: 75 mg capsules as follows 1 cap (75 mg) PO BID X 5 days ≥ 40 75 mg PO BID 6.25

Sponsors & Collaborators

Principal Investigators

  • W. Abdullah Brooks, MD, MPH · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Bangladesh

Study Locations

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Entities

Drugs
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 NCT00707941 on ClinicalTrials.gov