Study of Shortened Treatment Options Using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for Rifampicin-Resistant Tuberculosis

What this Trial Is About

Researchers are evaluating treatment strategies for fluoroquinolone-susceptible multidrug-resistant or rifampin-resistant pulmonary tuberculosis FQ-S MDRRR-TB through the PRISM-TB trial. This international, multicenter Phase 23 clinical trial aims to identify the preferred duration of a combination regimen called BPaLM and to determine if this regimen is as effective as the current standard treatment over 73 weeks. Participants are randomly assigned to one of several treatment groups during two stages of the trial. Stage 1 includes three groups a control group receiving the standard 24-week BPaLM regimen, and two experimental groups receiving shorter BPaLM regimens of 17 weeks or a stratified approach of 13 or 24 weeks based on disease severity. Stage 2 continues with two groups the control regimen and the preferred BPaLM strategy identified from Stage 1. All study drugs are given orally daily, including bedaquiline, pretomanid, linezolid, and moxifloxacin, with doses and durations adjusted according to international guidelines and local standards of care. Participants will provide consent and undergo screening before randomization. During the study, they will be monitored for effectiveness using a primary outcome measure called Desirability of Outcome Ranking DOOR at 73 weeks. Safety is also assessed through tracking adverse events and laboratory tests. The study involves regular visits and evaluations, including chest radiographs and HIV testing, to ensure participant safety and adherence. The trial aims to enroll at least 400 participants across both stages and will continue until 2031.

Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis