FORMaT
Research type
Research Study
Full title
A multi-centre, randomised, multi-arm, adaptive platform trial in people with or without cystic fibrosis Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT)
IRAS ID
1007146
Contact name
Chris Rose'Meyer
Contact email
Sponsor organisation
University of Queensland
Eudract number
2020-000050-10
ISRCTN Number
ISRCTN67303903
Clinicaltrials.gov Identifier
Research summary
Mycobacterium abscessus (MABS) are a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans, often chest infections. People who have underlying lung conditions such as cystic fibrosis (CF) or bronchiectasis are more likely to get MABS chest infection. The number of people who get MABS chest infections is small, but these infections are becoming more common. Some MABS chest infections can be cleared without treatment whereas other MABS chest infections can result in long term MABS lung disease significantly impacting on the person’s quality of life. Currently, there are no guidelines for when to start treating MABS chest infections and the treatment regimens used can be administered for up to two years, but are often associated with significant side-effects. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) Trial is an adaptive, multi-arm, platform clinical trial designed to find out which combination of medications best treat Mycobacterium abscessus (MABS) chest infections. Initially, the design of the FORMaT trial will evaluate the standard medications prescribed to treat MABS lung disease as these standard medications have not been properly tested for treating this disease. The trial platform can also add new treatment arms into the trial as well as having the ability to remove any treatment arms deemed ineffective. The adaptive part of the trial allows the data to be analysed while the trial is ongoing and these results can be used to change the trial design in real-time. This means that we can quickly identify effective treatment arms and potentially allocate more people to the successful treatment arm/s.
The FORMaT Trial consists of two participant groups:
1. Intervention Group: Require medications to get rid of their MABS lung disease.
2. Observation Group: Have not met the criteria to treat MABS lung disease infection or have chosen not to take the medications.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/LO/0838
Date of REC Opinion
8 Jan 2025
REC opinion
Further Information Favourable Opinion