Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis

• Status: Recruiting
• Trial end date: 2027-10-01

Summary

This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).

• Phase: Phase 2

Details

• Lead Sponsor: Bill & Melinda Gates Medical Research Institute
• Collaborators: Global Alliance for TB Drug Development; Janssen Pharmaceutica; Otsuka Pharmaceutical Co., Ltd.
• Treatments: Bedaquiline; Diarylquinolines; Ethambutol; Isoniazid; Oxazolidinones; Pyrazinamide; Rifampin