A blueprint for a multi-disease, multi-domain Bayesian adaptive platform trial incorporating adult and paediatric subgroups: the Staphylococcus aureus Network Adaptive Platform trial

Robert K Mahar; Anna McGlothlin; Michael Dymock; Todd C Lee; Roger J Lewis; Thomas Lumley; Jocelyn Mora; David J Price; Benjamin R Saville; Tom Snelling; Rebecca Turner; Steven A Webb; Joshua S Davis; Steven Y C Tong; Julie A Marsh; SNAP Global Trial Steering Committee

doi:10.1186/s13063-023-07718-x

A blueprint for a multi-disease, multi-domain Bayesian adaptive platform trial incorporating adult and paediatric subgroups: the Staphylococcus aureus Network Adaptive Platform trial

Trials. 2023 Dec 6;24(1):795. doi: 10.1186/s13063-023-07718-x.

Authors

Robert K Mahar^#^{1

2

3}, Anna McGlothlin^#⁴, Michael Dymock⁵, Todd C Lee⁶, Roger J Lewis^{4

7}, Thomas Lumley⁸, Jocelyn Mora⁹, David J Price^{10

9}, Benjamin R Saville^{4

11}, Tom Snelling^{5

12

13}, Rebecca Turner¹⁴, Steven A Webb^{15

16}, Joshua S Davis^{17

18}, Steven Y C Tong^{9

19}, Julie A Marsh⁵; SNAP Global Trial Steering Committee

Collaborators

SNAP Global Trial Steering Committee:
Asha Bowen, Matthew Cheng, Nick Daneman, Joshua Davis, Anna Goodman, George Heriot, Todd C Lee, Roger Lewis, David Lye, Julie Marsh, Anna McGlothlin, Zoe McQuilten, Jocelyn Mora, Susan Morpeth, David Paterson, David Price, Jason Roberts, Owen Robinson, Matthew Scarborough, Steven Tong, Sebastiaan van Hal, Genevieve Walls, Steve Webb, Lynda Whiteway, Dafna Yahav

Affiliations

¹ Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Parkville, Victoria, Australia. robert.mahar@unimelb.edu.au.
² Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia. robert.mahar@unimelb.edu.au.
³ Centre for Data Science, Queensland University of Technology, Brisbane, Queensland, Australia. robert.mahar@unimelb.edu.au.
⁴ Berry Consultants LLC, Austin, Texas, USA.
⁵ Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia.
⁶ Division of Infectious Diseases, Department of Medicine, McGill University, Montreal, Canada.
⁷ Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California, USA.
⁸ Department of Statistics, University of Auckland, Auckland, New Zealand.
⁹ Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Parkville, Victoria, Australia.
¹⁰ Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Parkville, Victoria, Australia.
¹¹ Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
¹² Department of Infectious Diseases, Perth Children's Hospital, Perth, Western Australia, Australia.
¹³ Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
¹⁴ Medical Research Council Clinical Trials Unit at University College London, London, United Kingdom.
¹⁵ St John of God Healthcare, Perth, Western Australia, Australia.
¹⁶ Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
¹⁷ Department of Infectious Diseases, John Hunter Hospital, Newcastle, New South Wales, Australia.
¹⁸ Menzies School of Health Research, Royal Darwin Hospital, Darwin, Northern Territory, Australia.
¹⁹ Victorian Infectious Diseases Service, Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.

^# Contributed equally.

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 registration NCT05137119 . Registered on 30 November 2021.

Keywords: Adaptive; Bayesian; Platform; Randomised; Staphylococcus aureus; Trial.

Publication types

Clinical Trial

MeSH terms

Adult
Bayes Theorem
Child
Humans
Sepsis*
Staphylococcal Infections* / diagnosis
Staphylococcus aureus

Associated data

ClinicalTrials.gov/NCT05137119

Abstract

Publication types

MeSH terms

Associated data

Grants and funding