Finding the Best Treatment Options for Mycobacterium Abscessus Lung Disease to Improve Health and Reduce Side Effects

What this Trial Is About

Mycobacterium abscessus MABS is a group of rapidly growing bacteria resistant to many drugs, causing lung infections that can lead to serious health problems, decreased lung function, and higher risk during lung transplants. The prevalence of MABS infections is increasing globally despite the relatively small number of affected people. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment FORMaT trial aims to identify the best treatment combinations to improve health outcomes while reducing side effects and treatment burden. It also seeks to develop biomarkers to guide treatment decisions and assess disease severity in patients with MABS pulmonary disease MABS-PD. The trial is an ongoing, adaptive study designed to test and improve combinations of therapies for both children and adults with MABS-PD. Participants receive various drug treatments including intravenous therapies such as amikacin, tigecycline, cefoxitin or imipenem combined with oral antibiotics like azithromycin, clarithromycin, and clofazimine. The study includes phases of intensive intravenous therapy followed by consolidation therapy with oral andor inhaled antibiotics. Treatments can be adjusted based on tolerance and microbiological response, with new therapies added or removed as evidence evolves. Participants are involved in screening, treatment, and follow-up visits extending up to 62 weeks. The study monitors microbiological clearance of infection alongside treatment tolerance. Assessments include lung function tests, chest CT scans, quality of life questionnaires, six-minute walk tests, and evaluation of treatment safety and resistance. Researchers also study health costs and reasons for early withdrawal. This comprehensive monitoring helps understand how treatments affect disease control, lung health, and patient well-being over time.

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment