Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

455

Participants

Timeline

Start Date

July 30, 2018

Primary Completion Date

July 1, 2021

Study Completion Date

June 10, 2022

Conditions
Tuberculosis, PulmonaryTuberculosis, Multidrug-ResistantTuberculosis, MDRTuberculosisDrug-Resistant Tuberculosis
Interventions
DRUG

Pretomanid

200 mg tablets

DRUG

Bedaquiline

100 mg tablets

DRUG

Moxifloxacin

400 mg tablets

DRUG

Pyrazinamide

500 mg tablets

DRUG

HRZE

isoniazid 75 mg plus rifampicin 150 mg plus pyrazinamide 400 mg plus ethambutol 275 mg combination tablets

DRUG

HR

isoniazid 75 mg plus rifampicin 150 mg combination tablets

Trial Locations (26)

1104

Lung Center of Philippines, Manila

1230

Tropical Disease Foundation, Manila

2092

CHRU, Helen Joseph Hospital, Johannesburg

2109

Case Western Reserve University, Kampala

2571

PHRU, Tshepong Hospital, Klerksdorp

3216

THINK, Pietermaritzburg

4001

Enhancing Care Foundation, Durban

4015

CHRU, King Dinuzulu, Durban

7070

CHRU, Empilweni TB Hospital, Port Elizabeth

7530

TASK, Cape Town

7700

University of Cape Town Lung Institute, Cape Town

107014

Moscow City Research and Practice Tuberculosis Treatment Centre, Moscow

107564

Central TB Research Institute of the Federal Agency of Scientific Organizations, Moscow

119991

Research Institute of Phthisiopulmonology of I. M. Sechenov First Moscow State Medical University, Moscow

191036

Research Institute of the Phthisiopulmonology, Saint Petersburg

620039

Ural Research Institute of Phthisiopulmonology, Yekaterinburg

Unknown

Evandro Chagas, Rio de Janeiro

FIOCRUZ, Rio de Janeiro

Institut Perubatan Respiratori, Kuala Lumpur

Ifakara Health Institute, Bagamoyo

NIMR-Mbeya, Mbeya

Kilimanjaro Clinical Research Institute, Moshi

Mwanza Intervention Trials Unit, Mwanza

0101

National Center for Tuberculosis and Lung Diseases, Tbilisi

0250

Madibeng Centre for Research, Brits

0152

Setshaba Research Centre, Soshanguve

All Listed Sponsors
lead

Global Alliance for TB Drug Development

OTHER

NCT03338621 - Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients | Biotech Hunter | Biotech Hunter