Academic Journal
Finding the optimal regimen for Mycobacteroides abscessus treatment (FOR Ma T) in people with Mycobacteroides abscessus pulmonary disease: a multicentre, randomised, multi-arm, adaptive platform trial
| Τίτλος: | Finding the optimal regimen for Mycobacteroides abscessus treatment (FOR Ma T) in people with Mycobacteroides abscessus pulmonary disease: a multicentre, randomised, multi-arm, adaptive platform trial |
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| Συγγραφείς: | Jong T, Baird T, Barr HL, Bell S, Bigirumurame T, Brady K, Burke A, Byrnes J, Caudri D, Clark JE, Coin LJM, Goh F, Grimwood K, Hicks D, Jayawardana K, Joshi S, Lee K, Qvist T, Reid D, Rice M, Roberts JA, Rogers G, Shackleton C, Sly PD, Smyth AR, Stevens L, Stockwell R, Tarique A, Taylor S, Thomson R, Tiddens HAWM, Wang XF, Wason J, Wainwright C |
| Πηγή: | BMJ Open, 21 September 2025 |
| Στοιχεία εκδότη: | BMJ Publishing Group |
| Έτος έκδοσης: | 2025 |
| Συλλογή: | Newcastle University Library ePrints Service |
| Περιγραφή: | © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.Introduction Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance. Methods and analysis FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for 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 ... |
| Τύπος εγγράφου: | article in journal/newspaper |
| Περιγραφή αρχείου: | application/pdf |
| Γλώσσα: | unknown |
| Relation: | https://eprints.ncl.ac.uk/308056; https://eprints.ncl.ac.uk/fulltext.aspx?url=308056/8D1D5B2D-BD12-410B-BB12-56232BD47BF9.pdf&pub_id=308056 |
| Διαθεσιμότητα: | https://eprints.ncl.ac.uk/308056 |
| Rights: | https://creativecommons.org/licenses/by-nc/4.0/ |
| Αριθμός Καταχώρησης: | edsbas.C386445F |
| Βάση Δεδομένων: | BASE |
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