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

Starting soon · Phase 3

Conditions studied: Rifampicin-Resistant Tuberculosis

In brief

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.

Key facts

Study ID: NCT07675954
Run by: Seoul National University Hospital
People needed: 294
Starts: 2026-10-01
Expected to finish: 2032-06-01
Last updated by the study team: 2026-06-30

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Willing and able to voluntarily provide written informed consent to participate in the study prior to initiation of any study-related procedures. For participants under the age of 18 years, signed consent may be obtained from the child's biological parent, legal guardian, or primary caregiver in the presence of the child. Minor participants must also be willing to provide written assent for study participation.
To the best of their knowledge and abilities at screening, participants must be willing and able to adhere to the complete follow-up schedule and all study procedures.
Male or female participants aged 15 years or older.
Participant requires treatment for pulmonary rifampicin-resistant tuberculosis based on one or more of the following:
Documented molecular drug susceptibility testing, such as TB nucleic acid amplification test, line probe assay, targeted next-generation sequencing, or culture-based phenotypic drug susceptibility testing on a sample obtained from the participant within 8 weeks prior to screening, even if rifampicin resistance is not re-confirmed on a sample obtained at screening; or
Documented or self-reported clinical symptoms or signs of pulmonary tuberculosis disease, with or without radiological changes consistent with pulmonary tuberculosis, and evidence of close contact with someone with confirmed rifampicin-resistant tuberculosis which, in the opinion of the site investigator, indicates significant exposure and a clinical decision has been made to treat the participant for rifampicin-resistant tuberculosis in routine care; or
Documented peripheral tuberculosis lymphadenitis or tuberculosis pleurisy with confirmed rifampicin-resistant Mycobacterium tuberculosis on lymph node biopsy or pleural fluid aspiration, along with documented symptoms or signs suggestive of pulmonary tuberculosis without culture confirmation.
Not yet started rifampicin-resistant tuberculosis treatment, or initiated rifampicin-resistant tuberculosis treatment in routine care within 10 days prior to enrolment.
Body weight of at least 30 kg.
Documented HIV status and/or willing to undergo HIV testing.
Participants living with HIV must be on antiretroviral therapy, or due to start antiretroviral therapy within 2 months of enrolment, regardless of CD4 count, provided they are clinically stable in the opinion of the site investigator.
Pregnant women in any trimester and breastfeeding women are eligible for inclusion.

You may not qualify if…

Two or more of the following four drug groups cannot be used: bedaquiline or clofazimine; delamanid or pretomanid; linezolid or delpazolid; levofloxacin or moxifloxacin, due to any of the following:
Documented Mycobacterium tuberculosis resistance in the current or prior treatment episode;
Prior exposure of 1 month or longer, unless protocol-defined exceptions are met;
Absolute contraindications to the relevant study drugs;
Use of prohibited concomitant medications within 14 days prior to enrolment.
Ongoing treatment for rifampicin-resistant tuberculosis for more than 10 days in the current tuberculosis episode.
Isolated extrapulmonary tuberculosis without pulmonary involvement.
Extrapulmonary tuberculosis, with or without concurrent pulmonary tuberculosis, involving the central nervous system, osteoarticular sites, pericardium, or disseminated/miliary disease.
Any of the following laboratory or ECG abnormalities:
A. Alanine transaminase or aspartate transaminase >120 U/L; B. Total bilirubin >2.4 mg/dL; C. Estimated glomerular filtration rate by the CKD-EPI equation <30 mL/min/1.73 m²; D. Serum potassium <3.2 mmol/L; E. QTcF >480 msec.
Atrioventricular block, second or third degree; current or previous history of clinically significant ventricular arrhythmias or long QT syndrome; or family history of long QT syndrome or sudden cardiac death.
Any condition or circumstance which, in the opinion of the investigator, based on information available at the time of screening, raises concerns regarding the participant's safety or ability to participate in the trial or the integrity of the study data.

Where it is running

Perinatal HIV Research Unit, PHRU-Matlosana, Tshepong Hospital — Klerksdorp, North West, South Africa
Desmond Tutu TB Centre, Brooklyn Chest Hospital Trial Unit — Cape Town, Western Cape, South Africa

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.