Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Pulmonary Disease Due to Mycobacteria (Diagnosis)
In brief
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.
Key facts
- Study ID
- NCT04310930
- Run by
- The University of Queensland
- People needed
- 300
- Starts
- 2020-03-02
- Expected to finish
- 2030-06-30
- Last updated by the study team
- 2026-05-11
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Royal Perth Hospital — Perth, Western Australia, Australia (enrolling)
- Royal Adelaide Hospital — Adelaide, Australia (enrolling)
- Sunshine Coast University Hospital — Birtinya, Australia (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- Queensland Children's Hospital — South Brisbane, Queensland, Australia (enrolling)
- The Prince Charles Hospital — Chermside, Australia (enrolling)
- Gold Coast University Hospital — Gold Coast, Australia (enrolling)
- Greenslopes Private Hospital, — Greenslopes, Australia (enrolling)
- Sir Charles Gairdiner Hospital — Nedlands, Australia (enrolling)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
- Austin Hospital — Heidelberg, Victoria, Australia (enrolling)
- Perth Children's Hospital — Perth, Australia (enrolling)
- The Alfred — Prahran, Australia (enrolling)
- Royal Melbourne Hospital — Parkville, Victoria, Australia (enrolling)
- Mater Adult Hospital — South Brisbane, Australia (enrolling)
- St George Hospital — Kogarah, New South Wales, Australia (enrolling)
- Kaohsiung Medical University Hospital — Kaohsiung City, Taiwan
- National Taiwan University Hospital — Taipei, Taiwan
- Belfast City Hospital — Belfast, United Kingdom
- Birmingham Children's Hospital — Birmingham, United Kingdom
- Birmingham Heartlands Hospital — Birmingham, United Kingdom
- Bristol Royal Hospital for Children — Bristol, United Kingdom
- Noah's Ark Childrens Hospital for Wales — Cardiff, United Kingdom
- Royal Hospital for Children and Young People, Edinburgh — Edinburgh, United Kingdom
- Western General Hospital — Edinburgh, United Kingdom
Full record on ClinicalTrials.gov
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