An evaluation of culture results during treatment for tuberculosis as surrogate endpoints for treatment failure and relapse.

ABSTRACT: It is widely acknowledged that new regimens are urgently needed for the treatment of tuberculosis. The primary endpoint in the Phase III trials is a composite outcome of failure at the end of treatment or relapse after stopping treatment. Such trials are usually both long and expensive. Valid surrogate endpoints measured during or at the end of treatment could dramatically reduce both the time and cost of assessing the effectiveness of new regimens. The objective of this study was to evaluate sputum culture results on solid media during treatment as surrogate endpoints for poor outcome. Data were obtained from twelve randomised controlled trials conducted by the British Medical Research Council in the 1970s and 80s in East Africa and East Asia, consisting of 6974 participants and 49 differ

SUBMITTER: Phillips PP 

PROVIDER: S-EPMC3648512 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature