Multidrug-resistant tuberculosis (MDR-TB) is a type of TB that does not respond to isoniazid and rifampicin. Delamanid is a recently approved drug for the treatment of MDR-TB. This study aims to examine the efficacy and safety of delamanid in the treatment of MDR-TB.
This double-blind, randomized, placebo-controlled, phase 3 trial included a total of 511 patients with pulmonary MD-TBR. The patients were randomly assigned in a 2:1 ratio to receive oral delamanid (n=341) or placebo (n=170). The primary outcome of the study was the time to sputum culture conversion over 6 months, along with the difference in the distribution of time to sputum culture conversion.
The findings suggested that 327 patients were culture-positive for MDR-TB, 226 in the delamanid group, and 101 in the placebo group. The median time to sputum culture conversion was 51 days in the delamanid group and 57 days in the placebo group, with a hazard ratio of 1.17. Of 511 total patients, 501 (98%) had at least one treatment-related adverse event and 136 patients (26.6%) had at least one treatment-related severe adverse event. The rate of treatment-related deaths was 4.4% in the delamanid group and 3.5% in the placebo group.
The research concluded that in patients with MD-TBR, the reduction in median time to sputum culture conversion over 6 months was not significant with the use of delamanid.