Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe University of Queensland

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

300 Participants
are divided into 5 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