Short-course Regimens for the Treatment of Pulmonary Tuberculosis

Summary

The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week. The first 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus rifabutin (Rb) (BMZRB) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and Rifabutin (Rb) (2 BMZRb/2 BMRb, Arm 1) The Second 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus delamanid (D or DLM); (BMZD) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM) (2 BMZD/2 BMD, Arm 2) The standard 26-week treatment control regimen which is two months of isoniazid, rifampin, ethambutol, and pyrazinamide (2HRZE) followed by four months of isoniazid and rifampin (4HR); (2HRZE/4HR, Arm 3) Target enrollment is 288 male and female participants (96/arm). participants. Participants will be followed until 78 weeks post-randomization, or until the last enrolled participant completes 52 weeks post-randomization, whichever comes first.

Timeline

Start

2023-11-21

Primary completion

2026-12-31

Completion

2027-12-31

Publications

• Kurbatova EV, Dooley KE, Carr W, Stout JE, Nuermberger EL, Phillips PPJ, Scott NA, Upton CM, Ignatius E, Haas M, Walter ND, Traxler RM, Brown NE, Boyd R, Bryant KE, Dixon MG, Savic R, Eichberg C, Hesseling A, Bark C, Benator DA, Muzanyi G, Twycross NS, Fox GJ, Pierre S, Burzynski J, Fitzgerald DW; TBTC Study 38 CRUSH-TB Team. Phase 2C clinical trial of novel short-course regimens for the treatment of pulmonary tuberculosis: TBTC study 38/CRUSH-TB design. Contemp Clin Trials. 2025 Nov;158:108075. doi: 10.1016/j.cct.2025.108075. Epub 2025 Sep 5.

Drugs

Indications