Bethelsdorp

Researchers are evaluating the safety and bactericidal activity of TBD09 combined with other drugs in adults with drug-sensitive pulmonary tuberculosis. This Phase 2, open-label, randomized trial aims to assess whether TBD09, when used with bedaquiline, pretomanid, and linezolid, shows potential as a safe and effective treatment option for this condition. Participants are divided into five groups, each receiving different doses or combinations of TBD09 alongside bedaquiline and pretomanid or linezolid for 28 days. Group 1 receives TBD09 100 mg three times weekly, Groups 2 to 4 receive TBD09 daily at increasing doses (100 mg, 300 mg, 500 mg), and Group 5 receives linezolid 600 mg daily instead of TBD09. All treatments are administered daily or three times weekly depending on the group. Throughout the study, participants are monitored for bactericidal activity from randomization through Day 28 and safety from screening through Day 35. Researchers evaluate serious adverse events, treatment-emergent adverse events, adverse events of special interest, and events leading to treatment discontinuation. These assessments help determine the safety and effectiveness of the study treatments over the course of participation.