FORMaT: A trial investigating the best treatment for Mycobacterium abscessus infections

Full title

FORMaT (Finding the Optimal Regimen for Mycobacterium Abscessus Treatment): A trial to find the most effective treatment for mycobacterium abscessus infections in people with CF and non- CF bronchiectasis

Study details

The aim of this study is to find the safest and most effective treatments for Mycobacterium abscessus (also called M. abscessus) infection in people with CF and non-CF bronchiectasis.

There are two groups in this study: an observation group and a treatment group.

• The observation group will consist of people who either:
  • have only had an M. abscessus infection once or 
  • do not currently have signs of M. abscessus infection and are not currently on a treatment for M. abscessus infection.
• The treatment group will consist of people who have a confirmed M. abscessus infection.

Participants in the observation group will be reviewed at regular visits (7 visits over 1 year). These will often coincide with routine clinic visits. Respiratory samples (such as a sputum sample) will be taken during visits. If a participant is not able to produce a sputum sample, a nebuliser containing hypertonic saline will be offered to help them to cough up phlegm.

At some visits, participants will asked to do a spirometry test (to measure lung function), a walk test and complete questionnaires.

Participants in the treatment group will be randomly assigned to different treatment plans. They will be given medications that are commonly used to treat M. abscessus infection. They will be monitored closely throughout their treatment.

As is standard practice for treating M. abscessus infections, they will undergo two phases of treatment: an intensive phase and a consolidation phase. During the intensive phase, participants will be randomly assigned to one of three treatment plans. They will have between 15 and 19 visits. For the consolidation phase, participants will again be randomly assigned to one of two treatment plans. They will have up to 10 clinic visits. 

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