A 6-Month MDR-END Plus Regimen for Rifampicin-Resistant Tuberculosis

Summary

This is a phase 3, open-label, randomized clinical trial in adults and adolescents aged 15 years or older who need treatment for rifampicin-resistant tuberculosis in South Africa.

The goal of this clinical trial is to learn whether a 6-month MDR-END Plus regimen works as well as current standard of care (SoC) treatment for rifampicin-resistant tuberculosis. The trial will also learn whether the MDR-END Plus regimen is safer and easier to tolerate than SoC regimens.

The main questions this trial aims to answer are:

* Does the MDR-END Plus regimen lead to a favorable treatment outcome 12 months after treatment is stopped, compared with SoC regimens?
* Do participants receiving the MDR-END Plus regimen have fewer important safety or tolerability problems during treatment and up to 90 days after treatment is stopped, compared with SoC regimens?

Researchers will compare the MDR-END Plus regimen with South African standard of care (SoC) treatment for rifampicin-resistant tuberculosis.

Participants will:

* Be randomly assigned to receive either the MDR-END Plus regimen or SoC treatment.
* Take tuberculosis medicines for about 6 months, although treatment may be extended in some cases.
* Attend study visits during treatment and after treatment is stopped.
* Have clinical assessments, blood tests, heart tracing tests, vision and nerve assessments, and tuberculosis tests.
* Be followed for 12 months after treatment is stopped.

Conditions

• Rifampicin-Resistant Tuberculosis

Interventions

DRUG

MDR-END Plus regimen

The investigational MDR-END Plus regimen consists of oral anti-tuberculosis drugs including bedaquiline, delamanid, delpazolid, levofloxacin, and pyrazinamide. Dosing and duration will follow the study protocol, with modifications based on body weight, drug susceptibility, drug suitability, and protocol-defined treatment extension criteria.

DRUG

Standard-of-care (SoC) treatment

Participants in the control arm will receive South African standard-of-care treatment for rifampicin-resistant tuberculosis according to national treatment guidance and site practice. The regimen may vary according to drug susceptibility results, drug suitability, and clinical judgement.

Sponsors & Collaborators

• Seoul National University

  collaborator OTHER

• Korea University

  collaborator OTHER

• National Institute of Health, Korea

  collaborator OTHER_GOV

• Desmond Tutu TB Centre

  collaborator OTHER

• Perinatal HIV Research Unit of the University of the Witswatersrand

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Jeongha Mok, MD, PhD · Pusan National University Hospital

• Jennifer Hughes, MBBCh · Desmond Tutu TB Centre, Stellenbosch University

• Jae-Joon Yim, MD, PhD · Seoul National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2032-06-30

Completion

2032-06-30

FDA Drug

Yes

Countries

• South Africa

Study Locations