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.