About this trial
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.
Eligibility criteria
Qualifiers
Eligibility into the Intervention Program, or;
Eligibility into the Observational Cohort.
Enrol directly into the Intervention Program, or;
Enrol into the Observational Cohort and transition into the Intervention Program once they satisfy the for this program which can occur at any time during the trial.
Disqualifiers
Clinical: Pulmonary symptoms and exclusion of other diagnoses.
Radiological: Nodular or cavitary opacities on chest radiograph or a chest high-resolution computed tomography (HRCT) scan showing multifocal bronchiectasis with multiple small nodules.
Microbiological: MABS positive culture results from at least two separate expectorated sputum samples.
Male or female participants of any age.
Trial design
Treatments tested in this trial
- Amikacin
- Tigecycline
- Imipenem
- Cefoxitin
- Azithromycin
- Clarithromycin
- Clofazimine
- Ethambutol
- Amikacin
- Linezolid
- co-trimoxazole
- Doxycycline
- Moxifloxacin
- Bedaquiline
- Rifabutin
Treatment groups
Sponsors and collaborators
The University of Queensland
Lead sponsor
Australian Government Department of Health and Ageing
Collaborator
Children's Hospital Foundation
Collaborator
Cystic Fibrosis Foundation
Collaborator
Newcastle University
Collaborator
Griffith University
Collaborator
Erasmus Medical Center
Collaborator
Monash University
Collaborator
University of Copenhagen
Collaborator
South Australian Health and Medical Research Institute
Collaborator
University of Melbourne
Collaborator
Murdoch Childrens Research Institute
Collaborator
QIMR Berghofer Medical Research Institute
Collaborator