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Clinical trial

An Open-Label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4-month Treatment of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) Compared to a 6-month Treatment of HRZE/HR (Control) in Adult Participants With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants With Drug Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB)

NCT03338621 is registered in ClinicalTrials.gov with Global Alliance for TB Drug Development as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-Label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4-month Treatment of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) Compared to a 6-month Treatment of HRZE/HR (Control) in Adult Participants With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants With Drug Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB)
Lead sponsor
Global Alliance for TB Drug Development
Phase
Phase 2/3
Overall status
Completed
Start date
July 30, 2018
Completion date
June 10, 2022
Enrollment
455 (actual)
Sites
26

Conditions

As the registry lists them; a condition with its own page is linked.

drug-resistant tuberculosis, tuberculosis, tuberculosis, mdr, tuberculosis, multidrug-resistant, tuberculosis, pulmonary