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

doi:10.1093/cid/ciac476

. 2022 Nov 30;75(11):2027-2034.

doi: 10.1093/cid/ciac476.

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

Steven Y C Tong¹, Jocelyn Mora¹, Asha C Bowen^{2

3}, Matthew P Cheng⁴, Nick Daneman⁵, Anna L Goodman^{6

7}, George S Heriot¹, Todd C Lee⁸, Roger J Lewis^{9

10

11}, David C Lye^{12

13

14

15}, Robert K Mahar^{16

17}, Julie Marsh¹⁸, Anna McGlothlin⁹, Zoe McQuilten^{19

20}, Susan C Morpeth²¹, David L Paterson²², David J Price^{1

16}, Jason A Roberts^{23

24}, J Owen Robinson^{25

26

27

28}, Sebastiaan J van Hal^{29

30}, Genevieve Walls²¹, Steve A Webb³¹, Lyn Whiteway³², Dafna Yahav³³, Joshua S Davis³⁴; Staphylococcus aureus Network Adaptive Platform (SNAP) Study Group

Collaborators, Affiliations

Collaborators

Staphylococcus aureus Network Adaptive Platform (SNAP) Study Group:
Nick Anagnostou, Sophia Archuleta, Eugene Athan, Emma Best, Max Bloomfield, Carly Botheras, Asha Bowen, Philip Britton, Kevin Brown, Anita Campbell, Hannah Carter, Matthew Cheng, Ka Lip Chew, Russel Lee Ming Chong, Geoff Coombs, Peter Daley, Nick Daneman, 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, Jennie Johnstone, Shirin Kalimuddin, Dana de Kretser, Andrea Kwa, Todd Lee, Amy Legg, Roger Lewis, Thomas Lumley, David Lye, Derek MacFadden, Robert Mahar, Isabelle Malhamé, Michael Marks, Julie Marsh, Marianne Martinello, Gail Matthews, Colin McArthur, Anna McGlothlin, Genevieve McKew, Brendan McMullan, Zoe McQuilten, Eliza Milliken, Jocelyn Mora, Susan Morpeth, Srinivas Murthy, Clare Nourse, Matthew O'Sullivan, David Paterson, Mical Paul, Neta Petersiel, Lina Petrella, David Price, Jason Roberts, Owen Robinson, Ben Rogers, Ben Saville, Marc Scheetz, Oded Scheuerman, Kevin Schwartz, Simon Smith, Tom Snelling, Christine Sommerville, Andrew Stewardson, Archana Sud, Steven Tong, Rebecca Turner, Sebastiaan van Hal, Nan Vasilunas, Lesley Voss, Genevieve Walls, Rachel Webb, Steve Webb, Lynda Whiteway, Heather Wilson, Terry Wuerz, Dafna Yahav

Affiliations

¹ Department of Infectious Diseases University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
² Department of Infectious Diseases, Perth Children's Hospital, Perth, Australia.
³ Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Perth, Australia.
⁴ Divisions of Infectious Diseases and Medical Microbiology, McGill University Health Centre, Montreal, Canada.
⁵ Division of Infectious Diseases, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.
⁶ Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
⁷ Department of Infection, St Thomas Hospital, Guy's and St Thomas NHS Foundation Trust, London, United Kingdom.
⁸ Clinical Practice Assessment Unit and Division of Infectious Diseases, McGill University, Montreal, Canada.
⁹ Berry Consultants, LLC, Austin, Texas, USA.
¹⁰ Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California, USA.
¹¹ Department of Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
¹² National Centre for Infectious Diseases, Singapore.
¹³ Department of Infectious Diseases, Tan Tock Seng Hospital, Singapore.
¹⁴ Yong Loo Lin School of Medicine, Singapore.
¹⁵ Lee Kong Chian School of Medicine, Singapore.
¹⁶ Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Parkville, Australia.
¹⁷ Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Australia.
¹⁸ Telethon Kids Institute, Perth Children's Hospital, Perth, Australia.
¹⁹ Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.
²⁰ Department of Haematology, Monash Health, Melbourne, Australia.
²¹ Department of Infectious Diseases, Middlemore Hospital, Auckland, New Zealand.
²² University of Queensland Centre for Clinical Research, Royal Brisbane and Women's Hospital Campus, Brisbane, Australia.
²³ University of Queensland Centre for Clinical Research, Faculty of Medicine, University of Queensland, Brisbane, Australia.
²⁴ Departments of Pharmacy and Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.
²⁵ Department of Infectious Diseases, Royal Perth Hospital, Perth, Australia.
²⁶ Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Australia.
²⁷ PathWest Laboratory Medicine, Perth, Australia.
²⁸ College of Science, Health, Engineering and Education, Murdoch University, Murdoch, Australia.
²⁹ Department of Microbiology and Infectious Diseases Royal Prince Alfred Hospital, Sydney, Australia.
³⁰ School of Medicine, University of Sydney, Sydney, Australia.
³¹ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.
³² Freelance Health Consumer Advocate, Adealide, South Australia, Australia.
³³ Infectious Diseases Unit, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.
³⁴ School of Medicine and Public Health and Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.

PMID: 35717634
PMCID: PMC9710697
DOI: 10.1093/cid/ciac476

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

Steven Y C Tong et al. Clin Infect Dis. 2022.

. 2022 Nov 30;75(11):2027-2034.

doi: 10.1093/cid/ciac476.

Authors

Collaborators

Staphylococcus aureus Network Adaptive Platform (SNAP) Study Group:
Nick Anagnostou, Sophia Archuleta, Eugene Athan, Emma Best, Max Bloomfield, Carly Botheras, Asha Bowen, Philip Britton, Kevin Brown, Anita Campbell, Hannah Carter, Matthew Cheng, Ka Lip Chew, Russel Lee Ming Chong, Geoff Coombs, Peter Daley, Nick Daneman, 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, Jennie Johnstone, Shirin Kalimuddin, Dana de Kretser, Andrea Kwa, Todd Lee, Amy Legg, Roger Lewis, Thomas Lumley, David Lye, Derek MacFadden, Robert Mahar, Isabelle Malhamé, Michael Marks, Julie Marsh, Marianne Martinello, Gail Matthews, Colin McArthur, Anna McGlothlin, Genevieve McKew, Brendan McMullan, Zoe McQuilten, Eliza Milliken, Jocelyn Mora, Susan Morpeth, Srinivas Murthy, Clare Nourse, Matthew O'Sullivan, David Paterson, Mical Paul, Neta Petersiel, Lina Petrella, David Price, Jason Roberts, Owen Robinson, Ben Rogers, Ben Saville, Marc Scheetz, Oded Scheuerman, Kevin Schwartz, Simon Smith, Tom Snelling, Christine Sommerville, Andrew Stewardson, Archana Sud, Steven Tong, Rebecca Turner, Sebastiaan van Hal, Nan Vasilunas, Lesley Voss, Genevieve Walls, Rachel Webb, Steve Webb, Lynda Whiteway, Heather Wilson, Terry Wuerz, Dafna Yahav

Affiliations

¹ Department of Infectious Diseases University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
² Department of Infectious Diseases, Perth Children's Hospital, Perth, Australia.
³ Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Perth, Australia.
⁴ Divisions of Infectious Diseases and Medical Microbiology, McGill University Health Centre, Montreal, Canada.
⁵ Division of Infectious Diseases, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.
⁶ Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
⁷ Department of Infection, St Thomas Hospital, Guy's and St Thomas NHS Foundation Trust, London, United Kingdom.
⁸ Clinical Practice Assessment Unit and Division of Infectious Diseases, McGill University, Montreal, Canada.
⁹ Berry Consultants, LLC, Austin, Texas, USA.
¹⁰ Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California, USA.
¹¹ Department of Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
¹² National Centre for Infectious Diseases, Singapore.
¹³ Department of Infectious Diseases, Tan Tock Seng Hospital, Singapore.
¹⁴ Yong Loo Lin School of Medicine, Singapore.
¹⁵ Lee Kong Chian School of Medicine, Singapore.
¹⁶ Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Parkville, Australia.
¹⁷ Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Australia.
¹⁸ Telethon Kids Institute, Perth Children's Hospital, Perth, Australia.
¹⁹ Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.
²⁰ Department of Haematology, Monash Health, Melbourne, Australia.
²¹ Department of Infectious Diseases, Middlemore Hospital, Auckland, New Zealand.
²² University of Queensland Centre for Clinical Research, Royal Brisbane and Women's Hospital Campus, Brisbane, Australia.
²³ University of Queensland Centre for Clinical Research, Faculty of Medicine, University of Queensland, Brisbane, Australia.
²⁴ Departments of Pharmacy and Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.
²⁵ Department of Infectious Diseases, Royal Perth Hospital, Perth, Australia.
²⁶ Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Australia.
²⁷ PathWest Laboratory Medicine, Perth, Australia.
²⁸ College of Science, Health, Engineering and Education, Murdoch University, Murdoch, Australia.
²⁹ Department of Microbiology and Infectious Diseases Royal Prince Alfred Hospital, Sydney, Australia.
³⁰ School of Medicine, University of Sydney, Sydney, Australia.
³¹ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.
³² Freelance Health Consumer Advocate, Adealide, South Australia, Australia.
³³ Infectious Diseases Unit, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.
³⁴ School of Medicine and Public Health and Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.

PMID: 35717634
PMCID: PMC9710697
DOI: 10.1093/cid/ciac476

Erratum in

Correction to: The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe.
[No authors listed] [No authors listed] Clin Infect Dis. 2023 Apr 17;76(8):1532-1533. doi: 10.1093/cid/ciac730. Clin Infect Dis. 2023. PMID: 36932686 Free PMC article. No abstract available.

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.

Keywords: Staphylococcus aureus; adaptive platform; bacteremia; bloodstream infection; randomized controlled trial.

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Conflict of interest statement

Potential conflicts of interest. A. M. is an employee of Berry Consultants LLC, in which capacity she is contracted as a consultant to numerous pharmaceutical and device companies on topics of statistical modeling and trial design, and reports grants and contracts unrelated to this work and consulting fees from Berry Consultants LLC. A. C. B. reports participation as a member of the CAMERA-2 data and safety monitoring board (DSMB) and as chair of the Skin Trial DSMB; a role as Vice President of the World Society of Pediatric Infectious Diseases and as Co-Chair, Australian and New Zealand Paediatric Infectious Diseases group of the Australasian Society of Infectious Diseases (ASID). D. L. P. reports grants or contracts made to institution and unrelated to this work from Shionogi, Merck, and Pfizer; consulting fees to author from Antimicrobial Resistance Action Fund and Spero Therapeutics; payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing, or educational events to author from Pfizer and Merck; support for attending meetings and/or travel to author from Pfizer; and an unpaid leadership or fiduciary role with ASID. J. A. R. reports contracts or grants paid to institution and unrelated to this work from the British Society of Antimicrobial Chemotherapy, bioMérieux, Pfizer, and QPEX; consulting fees paid to author from Gilead, Pfizer, Sandoz, Wolters Kluwer, Summit Pharma, and MSD; payment to author for lectures, presentations, speaker’s bureaus, manuscript writing, or educational events from MSD, Pfizer, and Cipla; an unpaid leadership or fiduciary role with Sepsis Clinical Care Standard, Australian Commission on Safety and Quality in Health Care, Consensus Guidelines on Prolonged Infusion of Beta-Lactam Antibiotics, American College of Clinical Pharmacy, Disease Modifying Treatment and Chemoprophylaxis, Australian National COVID-19 Clinical Evidence Taskforce, and Surviving Sepsis Guidelines. M. P. C. reports research support from the McGill Interdisciplinary Initiative in Infection and Immunity; research contracts from Cidara Therapeutics, Scynexis, and Amplyx; consulting fees as a scientific consultant for AstraZeneca; 3 pending patents (Methods for detecting tissue damage, graft-versus-host disease, and infections using cell-free DNA profiling; Methods for assessing the severity and progression of SARS-CoV-2 infections using cell-free DNA; and rapid identification of antimicrobial resistance and other microbial phenotypes using highly-multiplexed fluorescence in situ hybridization); stock options as a member of the scientific advisory board for GEn1E Lifesciences and Nomic Bio; and equity as co-founder of Kanvas Biosciences. R. J. L. is an employee of Berry Consultants, LLC, a statistical consulting firm that specializes in the design of adaptive and platform clinical trials. Berry Consultants received compensation for work included in the content of the submission. S. A. W. reports personal consulting fees from ClinicIQ pharma and Roche; an unpaid role as chair of Australian Clinical Trials Alliance; and stock and options with ClinicIQ. S. Y. C. T. reports a contract as a paid consultant for advice on clinical trial design, and consulting fees from Roivant Sciences as a paid consultant for advice on clinical trial design. T. C. L. reports research salary support from Fonds de Recherche Quebec–Sante, operating funds for other studies including CATCO from the CIHR; and operating funds for other studies from the McGill Interdisciplinary Institute Infection and Immunity. S. C. M. reports grants or contracts unrelated to this work from the HRC, and a nonremunerated role as the Chair of the New Zealand Microbiology Network. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

**Figure 1.**
Trial procedures and schedules. Abbreviation: D/C, discharge.

**Figure 2.**
Initial trial design. In each cell, the treatment that is often considered the usual standard of care is listed first and the “intervention” is listed second. Abbreviations: IV, intravenous; MRSA, methicillin-resistant *Staphylococcus aureus*; MSSA, penicillin-resistant, methicillin-susceptible *Staphylococcus aureus*; PSSA, penicillin-susceptible *Staphylococcus aureus*.

**Figure 3.**
Participant flow, randomization, and reveal of allocation timings. Abbreviations: EOS, early oral switch; IV, intravenous; MRSA, methicillin-resistant *Staphylococcus aureus*; MSSA, penicillin-resistant, methicillin-susceptible *Staphylococcus aureus*; PSSA, penicillin-susceptible *Staphylococcus aureus.*

See this image and copyright information in PMC

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References

1. Kourtis AP, Hatfield K, Baggs J, et al. Vital signs: epidemiology and recent trends in methicillin-resistant and in methicillin-susceptible Staphylococcus aureus bloodstream infections—United States. MMWR Morb Mortal Wkly Rep 2019; 68:214–9. - PMC - PubMed
1. Tong SYC, Davis JS, Eichenberger E, Holland TL, Fowler VG. Staphylococcus aureus infections: epidemiology, pathophysiology, clinical manifestations, and management. Clin Microbiol Rev 2015; 28:603–61. - PMC - PubMed
1. Coombs GW, Daley DA, Lee YT, Pang S; Australian Group on Antimicrobial Resistance . Australian Group on Antimicrobial Resistance (AGAR) Australian Staphylococcus aureus Sepsis Outcome Programme (ASSOP) annual report 2016. Commun Dis Intell 2018; 42:S2209-6051(18)00021-0. - PubMed
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1. Liu C, Strnad L, Beekmann SE, Polgreen PM, Chambers HF. Clinical practice variation among adult infectious diseases physicians in the management of Staphylococcus aureus bacteremia. Clin Infect Dis 2019; 69:530–33. - PMC - PubMed

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[1] Kourtis AP, Hatfield K, Baggs J, et al. Vital signs: epidemiology and recent trends in methicillin-resistant and in methicillin-susceptible Staphylococcus aureus bloodstream infections—United States. MMWR Morb Mortal Wkly Rep 2019; 68:214–9. - PMC - PubMed

[2] Kourtis AP, Hatfield K, Baggs J, et al. Vital signs: epidemiology and recent trends in methicillin-resistant and in methicillin-susceptible Staphylococcus aureus bloodstream infections—United States. MMWR Morb Mortal Wkly Rep 2019; 68:214–9. - PMC - PubMed

[3] Tong SYC, Davis JS, Eichenberger E, Holland TL, Fowler VG. Staphylococcus aureus infections: epidemiology, pathophysiology, clinical manifestations, and management. Clin Microbiol Rev 2015; 28:603–61. - PMC - PubMed

[4] Tong SYC, Davis JS, Eichenberger E, Holland TL, Fowler VG. Staphylococcus aureus infections: epidemiology, pathophysiology, clinical manifestations, and management. Clin Microbiol Rev 2015; 28:603–61. - PMC - PubMed

[5] Coombs GW, Daley DA, Lee YT, Pang S; Australian Group on Antimicrobial Resistance . Australian Group on Antimicrobial Resistance (AGAR) Australian Staphylococcus aureus Sepsis Outcome Programme (ASSOP) annual report 2016. Commun Dis Intell 2018; 42:S2209-6051(18)00021-0. - PubMed

[6] Coombs GW, Daley DA, Lee YT, Pang S; Australian Group on Antimicrobial Resistance . Australian Group on Antimicrobial Resistance (AGAR) Australian Staphylococcus aureus Sepsis Outcome Programme (ASSOP) annual report 2016. Commun Dis Intell 2018; 42:S2209-6051(18)00021-0. - PubMed

[7] Holland TL, Chambers HF, Boucher HW, et al. Considerations for clinical trials of Staphylococcus aureus bloodstream infection in adults. Clin Infect Dis 2019; 68:865–72. - PMC - PubMed

[8] Holland TL, Chambers HF, Boucher HW, et al. Considerations for clinical trials of Staphylococcus aureus bloodstream infection in adults. Clin Infect Dis 2019; 68:865–72. - PMC - PubMed

[9] Liu C, Strnad L, Beekmann SE, Polgreen PM, Chambers HF. Clinical practice variation among adult infectious diseases physicians in the management of Staphylococcus aureus bacteremia. Clin Infect Dis 2019; 69:530–33. - PMC - PubMed

[10] Liu C, Strnad L, Beekmann SE, Polgreen PM, Chambers HF. Clinical practice variation among adult infectious diseases physicians in the management of Staphylococcus aureus bacteremia. Clin Infect Dis 2019; 69:530–33. - PMC - PubMed

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

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

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