A Phase III placebo-controlled, double-blind, randomized trial to evaluate the efficacy and safety of TMC207 in subjects with sputum smear-positive pulmonary infection with multi-drug resistant Mycobacterium tuberculosis (MDR-TB)

The primary objective is to demonstrate that TMC207 added to a BR is superior to this BR plus placebo in regard to the proportion of subjects with favourable treatment outcome 60 weeks after randomization (i.e., 36 weeks of treatment and 24 weeks of treatment-free follow-up). A favourable treatment outcome requires confirmed culture conversion at Week 60.