Multi-Center Study of a Shortened Treatment Regimen Using Bedaquiline, Linezolid, Sitafloxacin, and Pyrazinamide for Drug-Sensitive and Drug-Resistant Pulmonary Tuberculosis

What this Trial Is About

Pulmonary tuberculosis TB remains a major global health challenge, especially in China, which has a high burden of both drug-susceptible and drug-resistant TB cases. Researchers are evaluating a new ultra-short-course treatment regimen called PAN-TB that aims to be effective for all active TB types. This regimen seeks to simplify treatment, reduce costs, shorten treatment duration to 2-3 months, and improve safety and success rates compared to standard care. The study compares multiple treatment regimens including a 2-month bedaquiline, linezolid, sitafloxacin, and pyrazinamide BLSZ regimen with possible extensions up to 13 weeks, a standard 6-month regimen using isoniazid, rifampicin, pyrazinamide, and ethambutol, and a 6-month bedaquiline, pretomanid, linezolid, and moxifloxacin BPaLM regimen with potential extension to 9 months if needed. Each treatment arm is tailored for either drug-susceptible or drug-resistant TB, and adjustments are made based on sputum smear or culture results and clinical symptoms. Participants will undergo regular follow-up visits for up to 18 months to monitor treatment outcomes and safety. Assessments include sputum culture conversion, clinical symptom evaluation, chest imaging, laboratory tests, and adverse event monitoring. The primary outcomes focus on unfavorable outcomes at 12 months and safety at 2 months, with additional secondary outcomes tracking longer-term treatment success and side effects. The study also aims to identify new biomarkers linked to treatment responses throughout the therapy.

A PAN-USR TB Multi-Center Trial