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Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Study acronym: FORMaT
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Publications: details revised at 1 of 1 entryv12
  2. Primary endpoints: 6 to 4
    • Eligibility criteria expanded, about 617 words
    • Secondary endpoints: 12 to 15
    • Collaborators: 13 to 12
    v11
  3. Site details revised at 1 of 50 sitesv10
  4. Primary completion date: Jun 30, 2024 to Jun 30, 2029
    • Study sites: 38 to 50
    • Study completion date: Aug 31, 2024 to Jun 30, 2030
    v9
  5. 2 versions Re-verified since Jun 18, 2023, no change to tracked fieldsv7-v8
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Jun 30, 2023 to Jun 30, 2024v6 Show 6 more changesShow less
    • Primary endpoints revised (6)
    • Study sites: 37 to 38
    • Study completion date: Aug 31, 2023 to Aug 31, 2024
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 11 to 12
    • Study description expanded, about 137 words
  2. Re-verified, no change to tracked fieldsv5
  3. Site details revised at 3 of 37 sitesv4
  4. Site contacts updated at 37 of 37 sitesv3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jun 2023 to Jun 30, 2023
    • Study completion date: Aug 2023 to Aug 31, 2023
    • Start date changed from estimate of Mar 2020 to Mar 2, 2020
    • Site details revised at 37 of 37 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Pulmonary Disease Due to Mycobacteria (Diagnosis)
Related terms Disease, Lung Diseases, Mycobacterium Infections, Nontuberculous
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov