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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
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Hjfgnfbh Uiyqrvzketfhec Swlgvfsjul &qkszqj Hxshikt dx Hlbhpdweavn STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
02.06.2025

Trial locations

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.

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 ID:
2024-512763-32-00
Protocol code:
APHP230852
Trial Phase:
Therapeutic confirmatory (Phase III)

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