| Title: |
Finding the optimal regimen for Mycobacteroides abscessus treatment (FORMaT) in people with Mycobacteroides abscessus pulmonary disease: a multicentre, randomised, multi-arm, adaptive platform trial. |
| Authors: |
Jong, Tiffany; Baird, Timothy; Barr, Helen Louise; Bell, Scott; Bigirumurame, Theophile; Brady, Kara; Burke, Andrew; Byrnes, Joshua; Caudri, Daan; Clark, Julia E; Coin, Lachlan JM; Goh, Felicia; Grimwood, Keith; Hicks, Daniel; Jayawardana, Kaushala; Joshi, Sri; Lee, Katherine; Qvist, Tavs; Reid, David; Rice, Megan; Roberts, Jason A; Rogers, Geraint; Shackleton, Claire; Sly, Peter D; Smyth, Alan R; Stevens, Luke; Stockwell, Rebecca; Tarique, Abdullah; Taylor, Steven; Thomson, Rachel; Tiddens, Harm AWM; Wang, Xiao Fang; Wason, James; Wainwright, Claire |
| Publisher Information: |
BMJ; //doi.org/10.1136/bmjopen-2024-096188 |
| Publication Year: |
2025 |
| Collection: |
Apollo - University of Cambridge Repository |
| Subject Terms: |
clinical trial; cystic fibrosis; health economics; lung diseases; pulmonary disease; quality of life; Humans; Anti-Bacterial Agents; Drug Therapy; Combination; Multicenter Studies as Topic; Mycobacterium abscessus; Mycobacterium Infections; Nontuberculous; Randomized Controlled Trials as Topic; Pragmatic Clinical Trials as Topic; Clinical Trials; Phase II as Topic; Phase III as Topic |
| Description: |
Peer reviewed: True ; Acknowledgements: The authors thank the members of the FORMaT CAG for their contributions and the participants for consenting to and taking part in the FORMaT study. They also thank the current and past members of the FORMaT TSC, iDSMB and DISC for their participation and contributions to the trial. The authors acknowledge the contribution of Andrew Bush, Paul Scuffham, Stuart Elborn, Jane Davies, Pierre-Régis Burgel, Valerie Waters, Felix Ratjen, Elizabeth Tullis, Ted Marras, Niels Høiby, Tacjana Pressler, Marianne Skov, Edward McKone, Catherine Byrnes and Christopher Coulter as Chief Investigators or Associate Investigators of the successful MRFF and US CFF grants that have funded the study. They further acknowledge Severine Navarro, who will be co-leading the T-cell substudy with DR. The authors thank all trial site principal investigators (PIs), trial site coordinators and other site personnel involved in the set-up and ongoing management of the trial and its participants at their respective sites (a list of current sites is available in online supplemental appendix 12). Thanks are also extended to the developers and authors of the HRQoL questionnaires used in this trial. The use of CFQ-R, EQ-5D, SGRQ, SF-36, PedsQL and CHU9D enables the assessment and understanding of the impact of MABS-PD and its treatment on patients’ HRQoL. Finally, the authors thank the developers of the MARS-5 questionnaire, which enables the assessment of participants’ self-reported adherence to trial interventions. ; Publication status: Published ; Funder: Anonymous Donor ; Funder: University of Queensland; FundRef: http://dx.doi.org/10.13039/501100001794 ; Funder: Thoracic Society of Australia and New Zealand; FundRef: http://dx.doi.org/10.13039/501100001247 ; 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 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text/xml; application/pdf |
| Language: |
English |
| Relation: |
https://www.repository.cam.ac.uk/handle/1810/390157 |
| Availability: |
https://www.repository.cam.ac.uk/handle/1810/390157 |
| Accession Number: |
edsbas.34F8D0C9 |
| Database: |
BASE |