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Actively Recruiting
Researchers are evaluating treatments for individuals with fluoroquinolone-susceptible multidrug-resistant or rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB) through a Phase 2/3 clinical trial called PRISM-TB. This international, open-label, randomized trial aims to identify the preferred treatment strategy using a combination of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) for different treatment durations. The study compares these new strategies to the current standard of care to determine if shorter or stratified treatments are as effective as the longer, established regimens over a 73-week period. The trial includes two stages. In Stage 1, participants are randomly assigned to one of three treatment arms: a control arm receiving the standard 24-week BPaLM regimen or one of two experimental arms with shorter or stratified treatment durations (13, 17, or 24 weeks depending on stratification). After interim analysis, Stage 2 will enroll additional participants randomized to either the control regimen or the preferred strategy identified from Stage 1. All study drugs are taken orally once daily, and treatment durations may be adjusted based on international guidelines and participant stratification. Participants undergo screening to confirm their TB diagnosis and treatment eligibility, including chest X-rays and HIV testing. Throughout the study, researchers evaluate treatment outcomes using the Desirability of Outcome Ranking (DOOR) at 73 weeks, monitoring for safety, adherence, and disease response. The study involves regular follow-ups, laboratory testing, and assessments to carefully track participants' health and treatment effectiveness over the study period.