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The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe

Version 2 2024-06-05, 11:45
Version 1 2023-05-29, 23:47
journal contribution
posted on 2024-06-05, 11:45 authored by Steven YC Tong, Jocelyn Mora, Asha C Bowen, Matthew P Cheng, Nick Daneman, Anna L Goodman, George S Heriot, Todd C Lee, Roger J Lewis, David C Lye, Robert K Mahar, Julie Marsh, Anna McGlothlin, Zoe McQuilten, Susan C Morpeth, David L Paterson, David J Price, Jason A Roberts, J Owen Robinson, Sebastiaan J van Hal, Genevieve Walls, Steve A Webb, Lyn Whiteway, Dafna Yahav, Joshua S Davis, Nick Anagnostou, Sophia Archuleta, Eugene Athan, Lauren Barina, Emma Best, Max Bloomfield, Jennifer Bostock, Carly BotherasCarly Botheras, Asha Bowen, Philip Britton, Hannah Burden, Anita Campbell, Hannah Carter, Matthew Cheng, Ka Lip Chew, Russel Lee Ming Chong, Geoff Coombs, Peter Daley, Jane Davies, Joshua Davis, Yael Dishon, Ravindra Dotel, Adrian Dunlop, Felicity Flack, Katie Flanagan, Hong Foo, Nesrin Ghanem-Zoubi, Stefano Giulieri, Anna Goodman, Jennifer Grant, Dan Gregson, Stephen Guy, Amanda Gwee, Erica Hardy, Andrew Henderson, George Heriot, Benjamin Howden, Fleur Hudson, Jennie Johnstone, Shirin Kalimuddin, Dana de Kretser, Andrea Kwa, Todd Lee, Amy Legg, Roger Lewis, Martin Llewelyn, Thomas Lumley, David Lye, Derek MacFadden, Robert Mahar, Isabelle Malhamé, Michael Marks, Marianne Martinello, Gail Matthews, Colin McArthur, Genevieve McKew, Brendan McMullan, Eliza Milliken, Susan Morpeth, Srinivas Murthy, Clare Nourse, Matthew O'Sullivan, David Paterson, Mical Paul, Neta Petersiel, Lina Petrella, Sarah Pett, David Price, Jason Roberts, Owen Robinson, Ben Rogers, Benjamin Saville, Matthew Scarborough, Marc Scheetz, Oded Scheuerman, Kevin Schwartz, Simon Smith, Tom Snelling, Marta Soares, Christine Sommerville, Andrew Stewardson, Neil Stone, Archana Sud, Robert Tilley, Steven Tong, Rebecca Turner, Jonathan Underwood, Sebastiaan van Hal, Lesley Voss, Rachel Webb, Steve Webb, Lynda Whiteway, Heather Wilson, Terry Wuerz
Abstract Staphylococcus aureus bloodstream (SAB) infection is a common and severe infectious disease, with a 90-day mortality of 15%–30%. Despite this, <3000 people have been randomized into clinical trials of treatments for SAB infection. The limited evidence base partly results from clinical trials for SAB infections being difficult to complete at scale using traditional clinical trial methods. Here we provide the rationale and framework for an adaptive platform trial applied to SAB infections. We detail the design features of the Staphylococcus aureus Network Adaptive Platform (SNAP) trial that will enable multiple questions to be answered as efficiently as possible. The SNAP trial commenced enrolling patients across multiple countries in 2022 with an estimated target sample size of 7000 participants. This approach may serve as an exemplar to increase efficiency of clinical trials for other infectious disease syndromes.

History

Journal

Clinical Infectious Diseases

Volume

75

Pagination

2027-2034

Location

Oxford, Eng.

ISSN

1058-4838

eISSN

1537-6591

Language

eng

Publication classification

C2 Other contribution to refereed journal

Issue

11

Publisher

Oxford University Press

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