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Study of bedaquiline, pretomanid, linezolid and moxifloxacin combination treatment for patients with multidrug-resistant tuberculosis in France

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with multidrug-resistant tuberculosis (MDR-TB), a form of tuberculosis that does not respond to standard medications. The study evaluates a new six-month treatment combination consisting of five medications: bedaquiline, pretomanid, linezolid, moxifloxacin, and clofazimine. This combination of drugs is being studied as a potential alternative to the current longer treatment options for MDR-TB.

The purpose of the study is to determine if this new shorter treatment works as well as the conventional longer treatments that have been used in France between 2006 and 2022. The medications will be taken by mouth daily for up to 24 weeks. The treatment success will be evaluated 18 months after starting the medication.

During the study, participants will receive the combination of these five medications in the form of tablets or capsules. The medications will be given in specific daily doses: bedaquiline 400 mg, pretomanid 200 mg, linezolid 600 mg, moxifloxacin 400 mg, and clofazimine 200 mg. This new treatment approach aims to provide a shorter and potentially more effective option for people with MDR-TB.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial diagnosis and treatment start

    After being diagnosed with rifampicin-resistant tuberculosis, you will begin a six-month treatment regimen.

    The treatment consists of a combination of five medications that need to be taken orally: bedaquiline, pretomanid, linezolid, moxifloxacin, and clofazimine.

  2. Step 2

    Treatment period

    The treatment duration is set for 6 months.

    It is essential to take all medications as prescribed without interrupting treatment for more than 4 consecutive weeks.

    If you are a woman of childbearing age, you must use effective contraception during treatment and for 6 months after completion.

    If you are a male patient who has not had a vasectomy, you must use effective contraception during treatment and for 3 months after completion.

  3. Step 3

    Follow-up period

    After completing the 6-month treatment, your progress will be monitored for up to 18 months from the treatment start date.

    The medical team will assess your treatment success according to standard definitions established by the World Health Organization.

  4. Step 4

    Study completion

    Your participation in the study will conclude after the 18-month assessment period.

    The final evaluation will determine if the treatment has been successful in treating the rifampicin-resistant tuberculosis.

Who can join the trial?

6 criteria

  • Must be 18 years of age or older
  • Must have confirmed tuberculosis that is resistant to a medicine called rifampicin (this resistance must be confirmed by laboratory tests)
  • Must be able and willing to provide informed consent (agreement to participate in the study) - this can be signed or witnessed if unable to read
  • Must agree to use effective birth control:
    • Women who can become pregnant must use birth control during treatment and for 6 months after
    • Men must use birth control during treatment and for 3 months after, unless they have had a vasectomy
    • Must have valid health insurance coverage or be eligible for state medical aid or emergency medical care

Who cannot join the trial?

13 criteria

  • Age below 18 years old
  • Known allergy or hypersensitivity to any of the study medications (bedaquiline, pretomanid, linezolid, or moxifloxacin)
  • Severe liver problems (indicated by liver enzyme tests more than 3 times the normal upper limit)
  • Pregnancy or breastfeeding
  • Serious heart conditions, including irregular heartbeat or heart rhythm problems
  • Severe kidney disease requiring dialysis (a procedure to filter blood when kidneys don't work properly)
  • Active substance abuse that could interfere with following the treatment plan
  • HIV infection with severely low CD4 count (below 100 cells/mm3)
  • Currently taking medications that could interact with the study drugs
  • Mental health conditions that would prevent understanding or following study procedures
  • Previous treatment with any of the study medications in the past 6 months
  • Participation in another clinical trial within the last 30 days
  • Any condition that the study doctor believes would make participation unsafe
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Investigated drugs

BPaLM is a combination treatment for multidrug-resistant tuberculosis (MDR-TB). It consists of four medications taken together: Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin. This is a shorter treatment option that takes six months, compared to traditional longer treatments for MDR-TB. The medication combination works together to fight the tuberculosis bacteria that have become resistant to other common TB drugs. The conventional MDR-TB treatment regimens (used as comparison in this study) typically involve a combination of multiple antibiotics that patients need to take for a much longer period, usually 18-24 months. These traditional treatments often include different combinations of various TB medications.

What is already known about the treatment

BPaLM - A novel six-month combination treatment regimen for multidrug-resistant tuberculosis (MDR-TB), consisting of bedaquiline, pretomanid, linezolid, and moxifloxacin. This oral medication regimen represents a significant advancement in TB treatment, offering a shorter alternative to conventional long-term therapies. The treatment works by targeting specific bacterial mechanisms to kill drug-resistant TB bacteria, with each component having a unique mode of action: bedaquiline inhibits bacterial ATP synthase, pretomanid is activated within the bacterial cells causing cellular damage, linezolid prevents bacterial protein synthesis, and moxifloxacin inhibits DNA replication in bacteria. This combination therapy belongs to the class of anti-tuberculosis medications and is currently being evaluated in clinical trials as a potentially more efficient treatment option compared to traditional 18-24 month MDR-TB regimens.

Investigated diseases

  • Rifampicin-resistant Tuberculosis

    A form of tuberculosis where the bacteria have developed resistance to rifampicin, one of the main antibiotics used to treat TB. The disease primarily affects the lungs, causing persistent cough, chest pain, and difficulty breathing. The bacteria can multiply and spread throughout the body, affecting various organs and tissues. Unlike regular tuberculosis, this variant is harder to eliminate due to its resistance to standard treatment. The infection typically develops gradually, with symptoms becoming more noticeable over time.

  • Multidrug-resistant Tuberculosis (MDR-TB)

    A severe form of tuberculosis that has developed resistance to at least two of the most powerful first-line TB medications. The condition typically begins in the lungs but can spread to other parts of the body. Patients may experience persistent cough, fever, night sweats, and weight loss. The infection progresses more slowly than regular TB, but symptoms tend to worsen over time if not addressed. The bacteria can remain dormant in the body for extended periods before becoming active.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512763-32-00Protocol codeAPHP230852Estimated enrolment50 patientsSponsorAssistance Publique Hopitaux De Paris

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