Short-course Rifapentine-based Treatment for Drug-sensitive Pulmonary Tuberculosis in Adults

What this Trial Is About

Tuberculosis TB remains a leading infectious disease worldwide, with treatment challenges including poor adherence to long and complex regimens. Researchers are evaluating high-dose rifapentine regimens to treat rifampicin-sensitive pulmonary tuberculosis with the aim of shortening treatment duration and reducing side effects and economic burden. This multicenter, prospective, randomized controlled study focuses on assessing the safety, effectiveness, and pharmacokineticspharmacodynamics of these regimens compared to the standard treatment. The study includes four treatment groups three experimental groups receiving rifapentine at doses of 10mgkg, 15mgkg, or 20mgkg combined with isoniazid, pyrazinamide, and moxifloxacin during an 8-week intensive phase, followed by a continuation phase of 9 weeks with rifapentine, isoniazid, and moxifloxacin and one comparator group receiving the World Health Organizations standard 26-week regimen with rifampicin, isoniazid, pyrazinamide, and ethambutol. The continuation phase may be extended up to 18 weeks if certain treatment response criteria are not met. Participants will be monitored through treatment and follow-up lasting up to 108 weeks after randomization. Researchers will evaluate treatment success rates, culture conversion at various time points, relapse rates, and adverse events throughout the study period. Safety assessments will include laboratory tests and clinical evaluations to monitor tolerability and drug effects, ensuring thorough observation during and after treatment completion.

Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)