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.

Timeline

Start

2026-10-01

Primary completion

2032-06

Completion

2032-06

Drugs

Indications