Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD.

NCT Number	NCT04310930
Lead Sponsor	The University of Queensland Collaborators: Australian Government Department of Health and Ageing, Children's Hospital Foundation, Cystic Fibrosis Foundation, Newcastle University, Griffith University, Erasmus Medical Center, Monash University, University of Copenhagen, South Australian Health and Medical Research Institute, University of Melbourne, Murdoch Childrens Research Institute, QIMR Berghofer Medical Research Institute
Conditions	Pulmonary Disease Due to Mycobacteria (Diagnosis)
Enrollment	300 participants
Start Date	2020-03-02
Primary Completion	2029-06-30 (estimated)
Study Completion	2030-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-11