About Us – FORMaT Drug Trial

About the FORMaT Trial

“Finding the Optimal Regimen for Mycobacterium abscessus Treatment” (FORMaT) is a multi-site, international, investigator led adaptive platform trial which aims to find the most effective and well tolerated treatment for Mycobacterium abscessus pulmonary disease (MABS-PD). Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics, and mycobacterial genomics and resistome.

University of Queensland

University of Queensland (UQ) is one of Australia’s leading research and teaching institutions, and strives for excellence through the creation, preservation, transfer and application of knowledge. For more than a century, UQ has educated and worked with outstanding people to deliver knowledge leadership for a better world. UQ is a globally connected, research-intensive university dedicated to advancing knowledge and generating innovative solutions to the complex challenges of contemporary society. UQ seeks to conduct research for the public good with the highest levels of integrity. UQ are the Sponsor for the Finding the Optimal Regimen for Mycobacterium abscessus (FORMaT) Trial – more information about the FORMaT Trial can be found on the main pages of this website.

How we began

In 2015, the Patient-Centred Outcomes Research Institute (PCORI) held a public meeting organised by the US NTM consortium on Non-Tuberculous Mycobacterial (NTM) infection. The key priority identified was the need for better, less toxic treatments with a lower therapeutic burden. Participants also prioritised “validating and using tools to measure Health Related Quality of Life (HRQoL) and developing disease specific activity and severity assessment tools”. In 2021 the European Multicentre Bronchiectasis Audit and Research Collaboration-European Lung Foundation (EMBARC-ELF) patient survey confirmed these priorities. The FORMaT platform was established with a patient-focused primary outcome of microbiological clearance of infection with tolerance in response to the research priorities identified by patients and their families.

FORMaT will investigate the impact of disease and antimicrobial exposure on MABS isolates from a global trial network and further develop and validate biomarkers of disease progression and clearance.

Finding the Optimal Regimen for Mycobacterium abscessus Treatment

About

About the FORMaT Trial

University of Queensland

How we began

Our People

Claire Wainwright

Andrew Burke

Kara Brady

Daniel Hicks

Felicia Goh

Megan Rice

Our Collaborators and Affiliates