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

Steven Y.C. 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

doi:10.1093/cid/ciac476

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

Steven Y.C. 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 HalGenevieve Walls, Steve A. Webb, Lyn Whiteway, Dafna Yahav, Joshua S. Davis^*

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

39 Scopus citations

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.

Original language	English
Pages (from-to)	2027-2034
Number of pages	8
Journal	Clinical Infectious Diseases
Volume	75
Issue number	11
DOIs	https://doi.org/10.1093/cid/ciac476
State	Published - 1 Dec 2022
Externally published	Yes

Funding

Funders	Funder number
CATCO
McGill Interdisciplinary Institute Infection and Immunity
Canadian Institutes of Health Research

Keywords

Staphylococcus aureus
adaptive platform
bacteremia
bloodstream infection
randomized controlled trial

Access to Document

10.1093/cid/ciac476

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Tong, S. Y. C., Mora, J., Bowen, A. C., Cheng, M. P., Daneman, N., Goodman, A. L., Heriot, G. S., Lee, T. C., Lewis, R. J., Lye, D. C., Mahar, R. K., Marsh, J., McGlothlin, A., McQuilten, Z., Morpeth, S. C., Paterson, D. L., Price, D. J., Roberts, J. A., Robinson, J. O., ... Davis, J. S. (2022). The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe. Clinical Infectious Diseases, 75(11), 2027-2034. https://doi.org/10.1093/cid/ciac476

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title = "The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe",

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",

author = "Tong, {Steven Y.C.} and Jocelyn Mora and Bowen, {Asha C.} and Cheng, {Matthew P.} and Nick Daneman and Goodman, {Anna L.} and Heriot, {George S.} and Lee, {Todd C.} and Lewis, {Roger J.} and Lye, {David C.} and Mahar, {Robert K.} and Julie Marsh and Anna McGlothlin and Zoe McQuilten and Morpeth, {Susan C.} and Paterson, {David L.} and Price, {David J.} and Roberts, {Jason A.} and Robinson, {J. Owen} and {Van Hal}, {Sebastiaan J.} and Genevieve Walls and Webb, {Steve A.} and Lyn Whiteway and Dafna Yahav and Davis, {Joshua S.}",

note = "Publisher Copyright: {\textcopyright} 2022 The Author(s). Published by Oxford University Press on behalf of Infectious Diseases Society of America.",

year = "2022",

month = dec,

day = "1",

doi = "10.1093/cid/ciac476",

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Tong, SYC, Mora, J, Bowen, AC, Cheng, MP, Daneman, N, Goodman, AL, Heriot, GS, Lee, TC, Lewis, RJ, Lye, DC, Mahar, RK, Marsh, J, McGlothlin, A, McQuilten, Z, Morpeth, SC, Paterson, DL, Price, DJ, Roberts, JA, Robinson, JO, Van Hal, SJ, Walls, G, Webb, SA, Whiteway, L, Yahav, D & Davis, JS 2022, 'The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe', Clinical Infectious Diseases, vol. 75, no. 11, pp. 2027-2034. https://doi.org/10.1093/cid/ciac476

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AU - Tong, Steven Y.C.

AU - Mora, Jocelyn

AU - Bowen, Asha C.

AU - Cheng, Matthew P.

AU - Daneman, Nick

AU - Goodman, Anna L.

AU - Heriot, George S.

AU - Lee, Todd C.

AU - Lewis, Roger J.

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AU - Mahar, Robert K.

AU - Marsh, Julie

AU - McGlothlin, Anna

AU - McQuilten, Zoe

AU - Morpeth, Susan C.

AU - Paterson, David L.

AU - Price, David J.

AU - Roberts, Jason A.

AU - Robinson, J. Owen

AU - Van Hal, Sebastiaan J.

AU - Walls, Genevieve

AU - Webb, Steve A.

AU - Whiteway, Lyn

AU - Yahav, Dafna

AU - Davis, Joshua S.

PY - 2022/12/1

Y1 - 2022/12/1

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AB - 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.

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

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