RecruitingPhase IIInterventional

Finding the best treatment for lung disease from infection with Mycobacterium abscessus

Mycobacterium abscessus (MABS) is a bacterium that can cause severe, long-term chest infections, especially in people with existing lung conditions like cystic fibrosis or bronchiectasis. Treating these infections is difficult because the bacteria resist many common medicines, and existing treatments often take up to two years and cause unpleasant side effects. The FORMaT trial tests different combinations of standard antibiotics to find out which mix is the most effective and easiest to tolerate. The study is "adaptive", meaning treatments that do not work well can be stopped early, while successful ones are given to more patients. Participants can either join an active treatment group—receiving medicines into a vein, through an inhaler, or as tablets—or an observation group that monitors the infection without immediate drug treatment. The trial is open to both adults and children across the UK.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Nottingham University Hospitals NHS Trust

Enrolment target

300

Start

02 Mar 2020

Estimated completion

30 Nov 2026

Mycobacterium abscessus pulmonary disease

What is this study about?

Mycobacterium abscessus (often called MABS) is a germ found naturally in soil and water. While it rarely harms healthy individuals, it can cause persistent, hard-to-treat chest infections in people who already live with lung conditions such as cystic fibrosis or bronchiectasis. These infections can cause a chronic cough, tiredness, and gradual damage to the lungs, which can have a major impact on everyday quality of life.

Treating MABS is challenging because the germ has natural defences against most standard antibiotics. Doctors often prescribe a combination of several powerful medicines for months or even years. However, these drug combinations have never been properly compared in clinical trials. As a result, doctors do not know for certain which mix works best, and the strong medicines frequently cause difficult side effects like sickness, fatigue, or hearing problems.

This study, known as the FORMaT trial, aims to solve this problem by testing different antibiotic combinations side by side. It uses an adaptable study design: as results come in, researchers can drop treatments that are not working well and focus on those that show the best results. By finding the most effective drug combinations, the study aims to help future patients clear the infection faster and with fewer side effects.

Key takeaways

The FORMaT trial tests the best combinations of antibiotics to treat Mycobacterium abscessus (MABS) lung infections.
It is open to both adults and children with a confirmed MABS chest infection.
Treatment lasts around one year and is split into a short intensive phase and a longer maintenance phase.
An observation-only group is available for patients who do not need immediate treatment.
The study aims to discover treatments that clear the infection faster while causing fewer side effects.
Participation is entirely voluntary, and you can leave the study at any time.

Who may be eligible?

This trial is open to both children and adults who have a confirmed Mycobacterium abscessus lung infection. To be considered, you usually need to have chest symptoms, signs of infection on a chest X-ray or CT scan, and sputum (phlegm) samples that have grown the MABS bacteria in a laboratory.

You may be able to join one of two groups. The "Intervention Group" is for people who need active antibiotic treatment right away. The "Observation Group" is for people who do not yet need medicines, or who choose to monitor the infection first with their medical team. People in the observation group can switch to the treatment group later if their health needs change.

Because the antibiotics used in this study can harm an unborn baby, you cannot take part if you are pregnant, planning a pregnancy, or breastfeeding. Both men and women taking part must agree to use effective contraception during the study and for at least three months after finishing treatment.

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.

You have a confirmed diagnosis of Mycobacterium abscessus (MABS) in your lungs.
You have chest symptoms and changes visible on a chest X-ray or CT scan.
Your phlegm (sputum) has tested positive for MABS in a laboratory.
You are not pregnant, planning to become pregnant, or breastfeeding.
You are willing to use reliable contraception during the trial and for three months after.

Answer every question to see your result.

What does participation involve?

If you take part in the treatment group, your care is divided into two main stages: an intensive phase followed by a consolidation (maintenance) phase. The intensive phase lasts around four weeks (or longer if tests show the bacteria are still present). During this time, you will receive antibiotics through a vein (intravenously), through a nebuliser (inhaler), and as tablets. Next, you will move into the consolidation phase, which lasts roughly 46 weeks. In this phase, you take daily antibiotic tablets, and some people may also use an inhaled antibiotic. In total, treatment takes around one year. You will have regular hospital appointments for chest scans, blood tests, hearing checks, and sputum samples so the team can monitor how well the treatment is working and check for any side effects.

Potential risks and benefits

Taking part may help clear your chest infection, but this cannot be guaranteed. The main benefit is helping doctors discover safer, more effective treatments for others with MABS in the future. Because the study uses powerful antibiotics, side effects are common. These can include nausea, diarrhoea, fatigue, or changes to your liver, kidney, or hearing function. You will also have chest scans that involve a very small amount of radiation, similar to standard medical X-rays. Your study doctor will monitor you closely throughout the trial and can adjust or pause your treatment if needed. Joining the study is completely your choice, and you can withdraw at any time without it affecting your standard NHS care.

Locations (47)

University Hospitals Bristol and Weston NHS Foundation Trust
City only
Bristol, England
Alder Hey Children's NHS Foundation Trust
City only
Liverpool, England
NHS Lothian
Approximate
Edinburgh, Scotland
NHS Lothian
Approximate
Edinburgh, Scotland
University Hospital Southampton NHS Foundation Trust
City only
Southampton, England
Manchester University NHS Foundation Trust
Unverified
Wythenshawe, England
Manchester University NHS Foundation Trust
Unverified
Manchester, England
Nottingham University Hospitals NHS Trust
Unverified
Nottingham, England
Nottingham University Hospitals NHS Trust
Unverified
Nottingham, England
Birmingham Women's and Children's NHS Foundation Trust
Unverified
Birmingham, England
University Hospitals Birmingham NHS Foundation Trust
Unverified
Birmingham, England
Cardiff and Vale University Health Board
Unverified
Penarth, Wales

Common questions

What is Mycobacterium abscessus?

It is an environmental germ that can cause stubborn, long-lasting chest infections, particularly in people with underlying lung conditions like cystic fibrosis.

Do I have to take antibiotics through a drip?

If you join the active treatment group, the first intensive phase does include antibiotics given into a vein (intravenously), alongside tablets or inhaled medicines.

How long will I be on treatment?

For most participants in the treatment group, treatment lasts about one year in total, starting with a short intensive phase followed by 46 weeks of maintenance therapy.

Can children join this trial?

Yes, this trial is open to people of all ages, including children, provided they meet the clinical criteria.

What if I experience unpleasant side effects?

The medical team monitors you very closely. They can adjust your doses, switch medications, or pause treatment if side effects become troublesome.

How to find out more

Alison Lloyd

Alison.Lloyd@nuh.nhs.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.