Context: Fixed-dose combinations (FDCs) of drugs for treatment of tuberculosis have been advocated to prevent the emergence of drug resistance.
Objective: To assess the efficacy and safety of a 4-drug FDC for the treatment of tuberculosis.
Design, Setting, And Patients: The Study C trial, a parallel-group, open-label, noninferiority, randomized controlled trial conducted in 11 sites in Africa, Asia, and Latin America between 2003 and 2008.
Background: Two drug-resistance surveys showed a very high prevalence of drug resistance among isolates obtained from patients with tuberculosis in 1991 and 1994 in New York, New York.
Methods: A cross-sectional survey in April 1997 and a survey of incident cases in April-June 2003 were conducted. The trend in the proportion of drug resistance in the 4 surveys was examined separately for prevalent and incident cases.