Phase 2b Study Comparing JDB0131 Benzenesulfonate Tablets and Delamanid in Combination Treatments for Rifampin-Resistant Tuberculosis

What this Trial Is About

Researchers are evaluating different doses of JDB0131 benzenesulfonate tablets compared with delamanid combined with bedaquiline, linezolid, levofloxacin or moxifloxacin, and clofazimine in patients with drug-resistant tuberculosis, including rifampicin-resistant strains. This phase 2b, multicenter, randomized, open-label clinical study aims to assess the efficacy, safety, and how the body processes these treatments over an 8-week period. Participants will be randomly assigned to one of three groups based on their fluoroquinolone resistance status. All groups receive bedaquiline, linezolid, and either levofloxacin or moxifloxacin or clofazimine for 8 consecutive weeks. Two groups receive different doses of JDB0131 100 mg or 200 mg twice daily, while the third group receives delamanid. Dosages of accompanying drugs are adjusted by body weight and other factors as specified. During the study, participants will undergo regular assessments including sputum culture tests to measure treatment effectiveness, monitoring of vital signs, electrocardiograms, laboratory tests for safety, and pharmacokinetic evaluations to understand drug levels in the body. Adverse events and medication usage will be tracked throughout the 8-week treatment. The primary outcome is the percentage of patients achieving sputum culture conversion during and after treatment.

A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets