Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
The FORMaT study is investigating the best treatments for a lung infection called Mycobacterium abscessus, or MABS-PD. This infection can cause serious problems for people's lungs, and currently, there isn't a single clear best way to treat it. This study aims to find more effective medicines that also have fewer side effects, making treatment easier and more successful for patients. Researchers will test various drug combinations and also look for new ways to understand the disease's severity and predict how well treatments might work. The overall goal is to improve the health and everyday life of people affected by MABS-PD.
At a glance
What is this study about?
The FORMaT study is trying to find the best treatments for a challenging lung infection called Mycobacterium abscessus, often shortened to MABS-PD. This infection is caused by a type of germ found in water and soil, and it can be quite persistent and difficult to treat because it's resistant to many common medicines. MABS-PD can lead to long-term lung problems, impacting everyday life and even making other medical procedures, like lung transplants, more complicated. While not many people have this specific infection, the numbers are growing worldwide.
Currently, doctors rely on certain guidelines to treat MABS-PD, but there isn't one perfect treatment plan that works for everyone. That's why the FORMaT study is so important. It's designed to compare different combinations of medicines, including some you might have heard of like azithromycin or clofazimine, to see which ones are most effective at clearing the infection while also being gentle on the body and causing the fewest side effects. The study is also looking for ways to better understand the disease, like developing tests that could help doctors decide when to start treatment and how serious the infection is.
This study is set up in a clever way, almost like a series of smaller experiments within the main trial. This allows researchers to continuously learn and improve. For example, if a treatment combination isn't working well or has too many side effects, it can be stopped, and new, more promising treatments can be quickly added to the study. This helps ensure that patients are always receiving care that is being carefully evaluated and improved upon, with the ultimate goal of finding the best possible approach to manage MABS-PD and improve patients' quality of life.
Key takeaways
- FORMaT study looks for better MABS-PD treatments.
- Tests different medicine combinations.
- Aims for effective treatment with fewer side effects.
- Contributes to understanding and improving MABS-PD care.
- You can participate in treatment or observation phases.
Who may be eligible?
To join the FORMaT study, you generally need to have a confirmed diagnosis of Mycobacterium abscessus lung disease (MABS-PD). This means your doctor will have found evidence of the infection through a combination of a chest X-ray or CT scan, lung symptoms, and positive lab tests from at least two separate sputum (phlegm) samples.
You might be able to join the 'Intervention Program' directly if you meet these specific medical requirements. This is where you would receive some of the study treatments. Alternatively, if you're not quite ready for the treatment part of the study but still have MABS-PD, you might be able to join the 'Observational Cohort'. In this group, researchers would simply observe your condition, and you could potentially move into the 'Intervention Program' later if your situation changes and you meet the necessary criteria.
The study is open to both children and adults of all genders. If you have other lung infections alongside MABS-PD or if your MABS infection has returned after previous treatment, you might still be eligible, provided you meet the other criteria.
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.
- Have you been diagnosed with Mycobacterium abscessus lung disease (MABS-PD)?
- Have your doctors confirmed this diagnosis with scans and lab tests?
- Are you able to attend regular appointments and tests?
- Are you over 18 years old? (Children may also be eligible)
What does participation involve?
If you join the FORMaT study, the exact details of your involvement will depend on whether you are in the 'Intervention Program' (receiving new treatments) or the 'Observational Cohort' (being monitored). For those in the 'Intervention Program', you would receive a combination of medicines, which could include injections (intravenous treatment) initially, followed by tablets or inhaled medicines. The study is designed to be flexible, meaning treatment plans might change over time based on what the researchers learn. You would have regular appointments for checks, scans, and possibly more lab tests to see how you are responding to treatment and to monitor for any side effects. The total duration of your participation would depend on the specific treatment plan and how long it takes to clear the infection, but would typically involve an initial intensive phase and a longer follow-up period. Your study team will explain the full schedule if you're eligible.
Potential risks and benefits
Locations (50)
- St George HospitalVerified postcodeKogarah, Australia· Recruiting
- Queensland Children's HospitalVerified postcodeSouth Brisbane, Australia· Recruiting
- Princess Alexandra HospitalVerified postcodeWoolloongabba, Australia· Recruiting
- Austin HospitalVerified postcodeHeidelberg, Australia· Recruiting
- Royal Melbourne HospitalVerified postcodeParkville, Australia· Recruiting
- Royal Perth HospitalVerified postcodePerth, Australia· Recruiting
- Royal Adelaide HospitalVerified postcodeAdelaide, Australia· Recruiting
- Sunshine Coast University HospitalVerified postcodeBirtinya, Australia· Recruiting
- Royal Prince Alfred HospitalVerified postcodeCamperdown, Australia· Not yet recruiting
- The Prince Charles HospitalVerified postcodeChermside, Australia· Recruiting
- Gold Coast University HospitalVerified postcodeGold Coast, Australia· Recruiting
- Greenslopes Private Hospital,Verified postcodeGreenslopes, Australia· Recruiting
Common questions
What is Mycobacterium abscessus (MABS-PD)?
It's a lung infection caused by a type of germ found in nature, which can be hard to treat because it's resistant to many common antibiotics.
Why is this study important?
It aims to find the most effective and safest treatment combinations for MABS-PD, as there isn't currently one clear best way to treat it.
What kind of treatments will be tested?
The study will test various combinations of medicines, some given as injections and others as tablets or inhaled medicines.
Who can join the study?
Both children and adults with a confirmed diagnosis of MABS-PD may be eligible. You can be in a treatment group or an observation group.
Can I leave the study if I change my mind?
Yes, your participation is voluntary, and you can withdraw from the study at any time without affecting your normal medical care.
How to find out more
Claire Wainwright, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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