Tuberculosis, Pulmonary Clinical Trial
Official title:
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB)
PRISM-TB is an international, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, noninferiority Phase 3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB). The trial objective is to evaluate whether stratified medicine treatment strategies for FQ-S MDR/RR-TB, defined by a pre-specified risk stratification algorithm, have noninferior efficacy to a one-size-fits-all control regimen (the local standard-of-care [SOC] regimen consistent with preferred regimen(s) in international guidelines), as measured by TB-related unfavorable outcomes at Week 73.
690 participants will be randomized to the following arms in a 1:1:1 randomization: Strategy 1 (control strategy): Control regimen for all with FQ-S MDR/RR-TB. The local SOC regimen consistent with preferred regimen(s) in international guidelines. In most cases this will be 26 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (6BPaLM). Doses and durations of each component may change based on the latest WHO guidelines and the local SOC. Strategy 2 (investigational strategy): 4BPaLM for all with FQ-S MDR/RR-TB. 17 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (4BPaLM). Strategy 3 (investigational strategy): 3BPaLM or 6BPaLM stratified medicine strategy for those with FQ-S MDR/RR-TB. 13 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (3BPaLM) for participants classified as having easier-to-treat TB and 26 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (6BPaLM) for participants classified as having harder-to-treat TB. ;
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