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

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...

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Autores principales: Tong, Steven Y C, Mora, Jocelyn, Bowen, Asha C, Cheng, Matthew P, Daneman, Nick, Goodman, Anna L, Heriot, George S, Lee, Todd C, Lewis, Roger J, Lye, David C, Mahar, Robert K, Marsh, Julie, McGlothlin, Anna, McQuilten, Zoe, Morpeth, Susan C, Paterson, David L, Price, David J, Roberts, Jason A, Robinson, J Owen, van Hal, Sebastiaan J, Walls, Genevieve, Webb, Steve A, Whiteway, Lyn, Yahav, Dafna, Davis, Joshua S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9710697/
https://www.ncbi.nlm.nih.gov/pubmed/35717634
http://dx.doi.org/10.1093/cid/ciac476
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author Tong, Steven Y C
Mora, Jocelyn
Bowen, Asha C
Cheng, Matthew P
Daneman, Nick
Goodman, Anna L
Heriot, George S
Lee, Todd C
Lewis, Roger J
Lye, David C
Mahar, Robert K
Marsh, Julie
McGlothlin, Anna
McQuilten, Zoe
Morpeth, Susan C
Paterson, David L
Price, David J
Roberts, Jason A
Robinson, J Owen
van Hal, Sebastiaan J
Walls, Genevieve
Webb, Steve A
Whiteway, Lyn
Yahav, Dafna
Davis, Joshua S
author_facet Tong, Steven Y C
Mora, Jocelyn
Bowen, Asha C
Cheng, Matthew P
Daneman, Nick
Goodman, Anna L
Heriot, George S
Lee, Todd C
Lewis, Roger J
Lye, David C
Mahar, Robert K
Marsh, Julie
McGlothlin, Anna
McQuilten, Zoe
Morpeth, Susan C
Paterson, David L
Price, David J
Roberts, Jason A
Robinson, J Owen
van Hal, Sebastiaan J
Walls, Genevieve
Webb, Steve A
Whiteway, Lyn
Yahav, Dafna
Davis, Joshua S
author_sort Tong, Steven Y C
collection PubMed
description 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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spelling pubmed-97106972022-12-01 The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe Tong, Steven Y C Mora, Jocelyn Bowen, Asha C Cheng, Matthew P Daneman, Nick Goodman, Anna L Heriot, George S Lee, Todd C Lewis, Roger J Lye, David C Mahar, Robert K Marsh, Julie McGlothlin, Anna McQuilten, Zoe Morpeth, Susan C Paterson, David L Price, David J Roberts, Jason A Robinson, J Owen van Hal, Sebastiaan J Walls, Genevieve Webb, Steve A Whiteway, Lyn Yahav, Dafna Davis, Joshua S Clin Infect Dis Viewpoints Article 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. Oxford University Press 2022-06-19 /pmc/articles/PMC9710697/ /pubmed/35717634 http://dx.doi.org/10.1093/cid/ciac476 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Viewpoints Article
Tong, Steven Y C
Mora, Jocelyn
Bowen, Asha C
Cheng, Matthew P
Daneman, Nick
Goodman, Anna L
Heriot, George S
Lee, Todd C
Lewis, Roger J
Lye, David C
Mahar, Robert K
Marsh, Julie
McGlothlin, Anna
McQuilten, Zoe
Morpeth, Susan C
Paterson, David L
Price, David J
Roberts, Jason A
Robinson, J Owen
van Hal, Sebastiaan J
Walls, Genevieve
Webb, Steve A
Whiteway, Lyn
Yahav, Dafna
Davis, Joshua S
The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe
title The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe
title_full The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe
title_fullStr The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe
title_full_unstemmed The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe
title_short The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe
title_sort staphylococcus aureus network adaptive platform trial protocol: new tools for an old foe
topic Viewpoints Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9710697/
https://www.ncbi.nlm.nih.gov/pubmed/35717634
http://dx.doi.org/10.1093/cid/ciac476
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