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.
Phase:
Phase 3
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh