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Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
Sponsor: Global Alliance for TB Drug Development
Summary
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients given BPaMZ for 17 Weeks ( or 4 months) vs. Standard HRZE/HR treatment given for 26 weeks (or 6 months) and Drug Resistant TB (DR-TB) patients given BPaMZ for 26 Weeks (or 6 months)
Official 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
455
Start Date
2018-07-30
Completion Date
2022-06-10
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Pretomanid
200 mg tablets
Bedaquiline
100 mg tablets
Moxifloxacin
400 mg tablets
Pyrazinamide
500 mg tablets
HRZE
isoniazid 75 mg plus rifampicin 150 mg plus pyrazinamide 400 mg plus ethambutol 275 mg combination tablets
HR
isoniazid 75 mg plus rifampicin 150 mg combination tablets
Locations (26)
Evandro Chagas
Rio de Janeiro, Brazil
FIOCRUZ
Rio de Janeiro, Brazil
National Center for Tuberculosis and Lung Diseases
Tbilisi, K'alak'i T'bilisi, Georgia
Institut Perubatan Respiratori
Kuala Lumpur, Malaysia
Lung Center of Philippines
Manila, Philippines
Tropical Disease Foundation
Manila, Philippines
Moscow City Research and Practice Tuberculosis Treatment Centre
Moscow, Russia
Central TB Research Institute of the Federal Agency of Scientific Organizations
Moscow, Russia
Research Institute of Phthisiopulmonology of I. M. Sechenov First Moscow State Medical University
Moscow, Russia
Research Institute of the Phthisiopulmonology
Saint Petersburg, Russia
Ural Research Institute of Phthisiopulmonology
Yekaterinburg, Russia
THINK
Pietermaritzburg, KwaZulu-Natal, South Africa
Madibeng Centre for Research
Brits, South Africa
TASK
Cape Town, South Africa
University of Cape Town Lung Institute
Cape Town, South Africa
Enhancing Care Foundation
Durban, South Africa
CHRU, King Dinuzulu
Durban, South Africa
CHRU, Helen Joseph Hospital
Johannesburg, South Africa
PHRU, Tshepong Hospital
Klerksdorp, South Africa
CHRU, Empilweni TB Hospital
Port Elizabeth, South Africa
Setshaba Research Centre
Soshanguve, South Africa
Mwanza Intervention Trials Unit
Mwanza, Tanzania, Tanzania
Ifakara Health Institute
Bagamoyo, Tanzania
NIMR-Mbeya
Mbeya, Tanzania
Kilimanjaro Clinical Research Institute
Moshi, Tanzania
Case Western Reserve University
Kampala, Uganda