Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    300
  • sponsor
    The University of Queensland
Updated on 25 January 2021

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

Description

Mycobacterium abscessus (MABS) are a group of non-tuberculous mycobacteria (NTM) found in water and soil habitats that exhibit high levels of intrinsic multi-drug resistance. They are recognised opportunistic human pathogens capable of causing chronic pulmonary disease (MABS-PD), predominantly in individuals with underlying inflammatory lung diseases

Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) is a platform trial evaluating microbiological, functional, radiological and quality of life outcomes of currently used antibiotic therapies along with health care costs and cost effectiveness for treating MABS PD in all age groups in both Australia and Internationally.

We aim to build an iterative, experimental clinical trial platform with adaptive properties. This will include two different cohorts recruited; an observation cohort and intervention cohort. Multiple treatment combinations will be evaluated in people with MABS-PD (intervention cohort) investigating different MABS subspecies, and strains with macrolide resistance. The platform will enable future novel treatments to efficiently enter the trial as they become available. The trial platform will include the current standard of care as a comparator arm; as evidence is accumulated new comparators may be incorporated. The trial platform will facilitate the evolution of optimal management for MABS lung disease with the primary outcome of microbial clearance with tolerance.

Details
Condition Pulmonary Disease Due to Mycobacteria (Diagnosis), Pulmonary Disease Due to Mycobacteria (Diagnosis), Pulmonary Disease Due to Mycobacteria (Diagnosis), Pulmonary Disease Due to Mycobacteria (Diagnosis), Pulmonary Disease Due to Mycobacteria (Diagnosis)
Treatment rifabutin, ethambutol, amikacin, moxifloxacin, bedaquiline, linezolid, Azithromycin, doxycycline, clarithromycin, Imipenem, Clofazimine, Cefoxitin, Co-trimoxazole, Tigecycline
Clinical Study IdentifierNCT04310930
SponsorThe University of Queensland
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

At least one positive MABS culture
Willingness and ability to comply with the study visit requirements

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
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