Phase 2 Study to Test New Drug Combinations for Treating Pulmonary Tuberculosis in Adults

What this Trial Is About

Researchers are evaluating new drug combinations for treating adults with drug-susceptible pulmonary tuberculosis TB in this Phase 2 randomized trial. The study aims to compare the early effectiveness and safety of these novel regimens against the current standard treatment, which includes isoniazid, rifampicin, pyrazinamide, and ethambutol. The main goal is to see if these new treatments improve early bacterial clearance and maintain acceptable safety over an 8-week period. Participants will be assigned to receive one of several drug regimens during the first 8 weeks. These include the standard treatment or experimental combinations containing bedaquiline, pretomanid, linezolid, TBI-223, or sutezolid at various doses. After the initial 8 weeks, all participants continue with standard therapy for an additional 18 weeks. Medication is taken orally daily, with dosing adjusted by weight and specific guidelines. During the 52-week study, which covers the full treatment and follow-up period, participants will have regular assessments including sputum tests to measure bacterial growth, blood tests to monitor safety, and clinical evaluations. The main outcomes measured are changes in bacterial growth over the first 6 weeks and the occurrence of significant side effects by week 8. Additional measurements include culture conversion rates, adverse events up to week 26, and overall cure rates at 52 weeks. Participants will be closely monitored throughout for safety and treatment response.

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis