AuthorisedTherapeutic confirmatory (Phase III)Interventional

Feasibility of the Application of a new Six-month Treatment for multidrug-resistant tuberculosis (MDR-TB) patients in France (FAST-MDR)

The FAST-MDR study is testing a new, shorter 6-month treatment plan for adults in France who have a tough kind of tuberculosis (TB) called multi-drug resistant TB (MDR-TB). This type of TB doesn't get better with standard medicines. The study wants to find out if this new, shorter treatment is effective. Researchers will compare how well people do on the new treatment after 18 months, looking for signs that the TB is gone and hasn't returned. They will also compare this to how people have done on older treatments. The goal is to see if this new treatment can offer a better and quicker way to help patients with MDR-TB.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

31 Jul 2025

Patients diagnosed at the study sites with rifampicinresistant tuberculosis during the recruitment period will be evaluated for study inclusion.

What is this study about?

This study, called FAST-MDR, is about finding a better way to treat a serious type of lung infection called tuberculosis (TB). Specifically, it focuses on a form of TB that is very stubborn and doesn't respond to the usual medicines. This is known as multi-drug resistant TB, or MDR-TB, and it can be very difficult to cure.

Currently, treating MDR-TB often involves taking many different medications for a long time, sometimes for a year or even longer. This can be very hard on patients, with many pills to take and potential side effects. The FAST-MDR study is testing a promising new treatment plan that only lasts for six months. This shorter treatment uses a combination of several different medicines that are thought to be effective against this resistant form of TB.

The main goal of the study is to see if this new 6-month treatment works well. Researchers will check if people who receive this new treatment remain free of TB 18 months after they started it. They will compare these results with information from patients who have received older treatments. If this new treatment proves successful, it could mean a much shorter, simpler, and potentially more effective way to treat MDR-TB, making a big difference for patients' lives.

Key takeaways

Tests a new 6-month treatment for severe, drug-resistant TB.
Aims to find a shorter, more effective way to cure MDR-TB.
Compares new treatment success to past standard treatments.
Involves a combination of five specific medications.
Participation lasts about 18 months for treatment and follow-up.
Open to adults aged 18 and over with newly diagnosed rifampicin-resistant TB.

Who may be eligible?

This study is looking for adult patients who have recently been diagnosed with a specific type of tuberculosis (TB).

To be included, your doctors need to have found that your TB infection is resistant to a key medicine called rifampicin. This is the main characteristic that makes it multi-drug resistant (MDR-TB).

If you have this specific kind of TB and are at least 18 years old, you might be able to take part in this study. The study does not exclude people based on their gender.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with tuberculosis (TB)?
Has your doctor confirmed that your TB is resistant to the medicine called rifampicin?
Are you able to commit to a 6-month treatment plan and 18 months of follow-up?
Are you currently living in France?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new active treatment, which involves taking a combination of several medicines: MOXIFLOXACIN, CLOFAZIMINE, PRETOMANID, LINEZOLID, and BEDAQUILINE. You would take these medicines for six months. During this time, and for some time afterwards, the study team would closely monitor your health to see how the treatment is working and to check for any side effects. You would have regular visits with the study doctors and nurses, who would perform assessments and ask about your well-being. The total duration of your participation, including the treatment and follow-up to check its long-term success, would be about 18 months from when you start the medication.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new, potentially more effective and shorter treatment for your multi-drug resistant TB, which could improve your health outcomes. However, like all medications, the drugs used in this new treatment may have side effects, and some are not yet fully understood. You will be closely monitored for any reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is MDR-TB?

MDR-TB stands for Multi-Drug Resistant Tuberculosis. It's a type of TB infection that doesn't get better with the two most common and effective medicines used to treat it.

What is the new treatment being tested?

The new treatment plan lasts for six months and involves a combination of several medicines: MOXIFLOXACIN, CLOFAZIMINE, PRETOMANID, LINEZOLID, and BEDAQUILINE.

How long would I be in the study?

If you join, the treatment itself lasts for 6 months. Researchers will then follow your progress for a total of 18 months from when you start the treatment to see how well it worked.

Will I know if I'm getting the new treatment or an old one?

This study specifically looks at results for people receiving the new 6-month treatment. Your results will then be compared to information from patients who have received older treatments in the past.

What happens if I get side effects?

The study team will closely monitor you throughout your participation. If you experience any side effects, report them immediately to the study doctors or nurses so they can provide appropriate care.