Overview

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Status:
Recruiting
Trial end date:
2023-08-31
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
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
Treatments:
Amikacin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Azithromycin
Bedaquiline
Cefotaxime
Cefoxitin
Clarithromycin
Clofazimine
Diarylquinolines
Doxycycline
Ethambutol
Imipenem
Linezolid
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Rifabutin
Tigecycline
Trimethoprim, Sulfamethoxazole Drug Combination
Criteria
Intervention Cohort Inclusion Criteria:

- Subjects with respiratory cultures positive for M. abscessus (MABS) (sub species
abscessus, sub species bolletii, or subspecies massiliense) are required to meet all 3
American Thoracic Society criteria (clinical, radiological and microbiological) for
MABS pulmonary disease (PD).

- Subjects with mixed NTM infections (slow growers + MABS) (adding ethambutol will be
permitted if required by the treating physician).

- Willingness and ability to comply with trial regimens and the study visit
requirements.

Intervention cohort Exclusion Criteria:

- Receiving active treatment for MABS within the previous 12 months, except azithromycin
for participants with cystic fibrosis and bronchiectasis.

- Healthy volunteers may not participate.

- Pregnancy

Observation Cohort Inclusion Criteria:

- At least one positive MABS culture

- Willingness and ability to comply with the study visit requirements.

Observation cohort Exclusion Criteria for:

- Receiving active treatment for MABS within the previous 12 months, except azithromycin
for participants with cystic fibrosis and bronchiectasis.

- Healthy volunteers may not participate.