Defining Surrogate Endpoints for Clinical Trials in Severe Falciparum Malaria.

ABSTRACT:

Background

Clinical trials in severe falciparum malaria require a large sample size to detect clinically meaningful differences in mortality. This means few interventions can be evaluated at any time. Using a validated surrogate endpoint for mortality would provide a useful alternative allowing a smaller sample size. Here we evaluate changes in coma score and plasma lactate as surrogate endpoints for mortality in severe falciparum malaria.

Methods

Three datasets of clinical studies in severe malaria were re-evaluated: studies from Chittagong, Bangladesh (adults), the African 'AQUAMAT' trial comparing artesunate and quinine (children), and the Vietnamese 'AQ' study (adults) comparing artemether with quinine. The absolute change, relative change, slope of the normalization ove

SUBMITTER: Jeeyapant A 

PROVIDER: S-EPMC5215574 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature