Short-course Regimens for the Treatment of Pulmonary Tuberculosis
Status:
Not yet recruiting
Trial end date:
2026-04-30
Target enrollment:
Participant gender:
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.