Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

August 31, 2031

Study Completion Date

August 31, 2031

Conditions
Tuberculosis, PulmonaryTuberculosis, Multidrug-ResistantTuberculosis, MDR
Interventions
DRUG

Bedaquiline

Frequency: daily Route of administration: oral

DRUG

Linezolid

Frequency: daily Route of administration: oral

DRUG

Pretomanid

Frequency: daily Route of administration: oral

DRUG

Moxifloxacin

Frequency: daily Route of administration: oral

DRUG

Control Arm FQ-S MDR/RR-TB regimen, designed according to latest international guidelines

The local SOC regimen consistent with preferred regimen(s) in international guidelines. In most cases this will be 24 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (6BPaLM). Doses and durations of each component may change based on the latest international guidelines and the local SOC.

Trial Locations (6)

Unknown

RECRUITING

National Center for Communicable Diseases, Ulaanbaatar

NOT_YET_RECRUITING

Institute of Chest Diseases, Kotri

NOT_YET_RECRUITING

Hospital Nacional Sergio E. Bernales, Lima

NOT_YET_RECRUITING

Policlínico SES, Lima

NOT_YET_RECRUITING

Mulago National Referral Hospital, Kampala

NOT_YET_RECRUITING

Hanoi Lung Hospital, Hanoi

All Listed Sponsors
collaborator

Johns Hopkins University

OTHER

lead

University of California, San Francisco

OTHER