Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
Status:
Recruiting
Trial end date:
2023-08-31
Target enrollment:
Participant gender:
Summary
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
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
The University of Queensland
Collaborators:
Australian Government Department of Health Australian Government Department of Health and Ageing Children's Hospital Foundation Cystic Fibrosis Foundation Erasmus Medical Center Griffith University Hôpital Cochin James Cook University, Queensland, Australia Monash University Murdoch Childrens Research Institute Newcastle University South Australian Health and Medical Research Institute University of Copenhagen University of Melbourne