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© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is a multifactorial Bayesian adaptive platform trial that aims to improve the way that S. aureus bloodstream infection, a globally common and severe infectious disease, is treated. In a world first, the SNAP trial will simultaneously investigate the effects of multiple intervention modalities within multiple groups of participants with different forms of S. aureus bloodstream infection. Here, we formalise the trial structure, modelling approach, and decision rules that will be used for the SNAP trial. By summarising the statistical principles governing the design, our hope is that the SNAP trial will serve as an adaptable template that can be used to improve comparative effectiveness research efficiency in other disease areas.

Trial registrationNCT05137119. Registered on 30 November 2021.

Details

Title
A blueprint for a multi-disease, multi-domain Bayesian adaptive platform trial incorporating adult and paediatric subgroups: the Staphylococcus aureus Network Adaptive Platform trial
Author
Mahar, Robert K. 1   VIAFID ORCID Logo  ; McGlothlin, Anna 2 ; Dymock, Michael 3 ; Lee, Todd C. 4 ; Lewis, Roger J. 5 ; Lumley, Thomas 6 ; Mora, Jocelyn 7 ; Price, David J. 8 ; Saville, Benjamin R. 9 ; Snelling, Tom 10 ; Turner, Rebecca 11 ; Webb, Steven A. 12 ; Davis, Joshua S. 13 ; Tong, Steven Y. C. 14 ; Marsh, Julie A. 3 ; Bowen, Asha; Cheng, Matthew; Daneman, Nick; Davis, Joshua; Goodman, Anna; Heriot, George; Lewis, Roger; Lye, David; Marsh, Julie; McQuilten, Zoe; Morpeth, Susan; Paterson, David; Price, David; Roberts, Jason; Robinson, Owen; Scarborough, Matthew; Tong, Steven; van Hal, Sebastiaan; Walls, Genevieve; Webb, Steve; Whiteway, Lynda; Yahav, Dafna

 University of Melbourne, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, Parkville, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X); Murdoch Children’s Research Institute, Clinical Epidemiology and Biostatistics Unit, Parkville, Australia (GRID:grid.1058.c) (ISNI:0000 0000 9442 535X); Queensland University of Technology, Centre for Data Science, Brisbane, Australia (GRID:grid.1024.7) (ISNI:0000000089150953) 
 Berry Consultants LLC, Austin, USA (GRID:grid.518594.4) 
 Telethon Kids Institute, Wesfarmers Centre of Vaccines and Infectious Diseases, Nedlands, Australia (GRID:grid.414659.b) (ISNI:0000 0000 8828 1230) 
 Department of Medicine, McGill University, Division of Infectious Diseases, Montreal, Canada (GRID:grid.14709.3b) (ISNI:0000 0004 1936 8649) 
 Berry Consultants LLC, Austin, USA (GRID:grid.518594.4); Harbor-UCLA Medical Center, Department of Emergency Medicine, Torrance, USA (GRID:grid.239844.0) (ISNI:0000 0001 0157 6501) 
 University of Auckland, Department of Statistics, Auckland, New Zealand (GRID:grid.9654.e) (ISNI:0000 0004 0372 3343) 
 University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Department of Infectious Diseases, Parkville, Australia (GRID:grid.483778.7) 
 University of Melbourne, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, Parkville, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X); University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Department of Infectious Diseases, Parkville, Australia (GRID:grid.483778.7) 
 Berry Consultants LLC, Austin, USA (GRID:grid.518594.4); Vanderbilt University Medical Center, Department of Biostatistics, Nashville, USA (GRID:grid.412807.8) (ISNI:0000 0004 1936 9916) 
10  Telethon Kids Institute, Wesfarmers Centre of Vaccines and Infectious Diseases, Nedlands, Australia (GRID:grid.414659.b) (ISNI:0000 0000 8828 1230); Perth Children’s Hospital, Department of Infectious Diseases, Perth, Australia (GRID:grid.518128.7) (ISNI:0000 0004 0625 8600); University of Sydney, Sydney School of Public Health, Faculty of Medicine and Health, Sydney, Australia (GRID:grid.1013.3) (ISNI:0000 0004 1936 834X) 
11  Medical Research Council Clinical Trials Unit at University College London, London, United Kingdom (GRID:grid.415052.7) (ISNI:0000 0004 0606 323X) 
12  St John of God Healthcare, Perth, Australia (GRID:grid.460013.0); Monash University, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Melbourne, Australia (GRID:grid.1002.3) (ISNI:0000 0004 1936 7857) 
13  John Hunter Hospital, Department of Infectious Diseases, Newcastle, Australia (GRID:grid.414724.0) (ISNI:0000 0004 0577 6676); Royal Darwin Hospital, Menzies School of Health Research, Darwin, Australia (GRID:grid.240634.7) (ISNI:0000 0000 8966 2764) 
14  University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Department of Infectious Diseases, Parkville, Australia (GRID:grid.483778.7); Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Victorian Infectious Diseases Service, Melbourne, Australia (GRID:grid.416153.4) (ISNI:0000 0004 0624 1200) 
Pages
795
Publication year
2023
Publication date
Dec 2023
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2898730934
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.