Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT03338621
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

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

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