Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

552

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

August 5, 2022

Study Completion Date

August 5, 2022

Conditions
Tuberculosis, Multidrug-ResistantExtensively Drug-Resistant TuberculosisTuberculosis, Pulmonary
Interventions
DRUG

Bedaquiline

DRUG

Pretomanid

DRUG

Moxifloxacin

DRUG

Linezolid

DRUG

Clofazimine

DRUG

Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.

Trial Locations (7)

2092

Helen Jospeh Hospital, Johannesburg

3650

THINK Clinical Trial Unit, Hillcrest, Durban

4091

King DinuZulu Hospital, Durban

Unknown

Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk

Doris Goodwin Hospital, Pietermaritzburg

Republican TB Hospital No. 2, Nukus

Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital, Tashkent

All Listed Sponsors
collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

Global Alliance for TB Drug Development

OTHER

collaborator

University College, London

OTHER

collaborator

Drugs for Neglected Diseases

OTHER

collaborator

Swiss Tropical & Public Health Institute

OTHER

collaborator

eResearch Technology, Inc.

INDUSTRY

collaborator

Ministry of Health, Republic of Uzbekistan

OTHER_GOV

collaborator

World Health Organization

OTHER

collaborator

Ministry of Public Health, Republic of Belarus

OTHER_GOV

collaborator

THINK TB & HIV Investigative Network

NETWORK

collaborator

University of Liverpool

OTHER

collaborator

Wits Health Consortium (Pty) Ltd

OTHER

collaborator

Rutgers, The State University of New Jersey

OTHER

collaborator

University of California, San Francisco

OTHER

lead

Medecins Sans Frontieres, Netherlands

OTHER

NCT02589782 - Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s) | Biotech Hunter | Biotech Hunter