This is a phase 2B, open label study, that will compare the safety and efficacy of three experimental regimens consisting of bedaquiline and delamanid in combination with different doses of BTZ-043, a novel antibiotic, in adult participants with newly diagnosed, drug-sensitive pulmonary tuberculosis. Participants will be assigned to receive either one of the three BTZ-043-containing regimens or a comparator regimen consisting of bedaquiline, delamanid and moxifloxacin. The objective is to find the optimal dose of BTZ-043 with the highest efficacy and safety to be used in subsequent studies.
|
Participant Group/Arm |
Drug Regimen, Dose, Duration |
|---|---|
|
Active Comparator: Arm 1 |
Drug: Moxifloxacin will be dosed at the licensed dose of 400 mg orally once daily for 16 weeks Drug: Bedaquiline will be dosed at 400 mg orally once daily for the first 2 weeks, followed by 100 mg orally once daily for 14 weeks Drug: Delamanid will be dosed at 300 mg orally once daily for 16 weeks |
|
Experimental: Arm 2 |
Drug: Bedaquiline will be dosed at 400 mg orally once daily for the first 2 weeks, followed by 100 mg orally once daily for 14 weeks Drug: Delamanid will be dosed at 300 mg orally once daily for 16 weeks Drug: BTZ-043 will be dosed at 500 mg orally once daily for 16 weeks |
|
Experimental: Arm 3 |
Drug: Bedaquiline will be dosed at 400 mg orally once daily for the first 2 weeks, followed by 100 mg orally once daily for 14 weeks Drug: Delamanid will be dosed at 300 mg orally once daily for 16 weeks Drug: BTZ-043 will be dosed at 1000 mg orally once daily for 16 weeks |
|
Experimental: Arm 4 |
Drug: Bedaquiline will be dosed at 400 mg orally once daily for the first 2 weeks, followed by 100 mg orally once daily for 14 weeks Drug: Delamanid will be dosed at 300 mg orally once daily for 16 weeks Drug: BTZ-043 will be dosed at 1500 mg orally once daily for 16 weeks |
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