1. Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe.
- Author
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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, and Hal, Sebastiaan J van
- Subjects
CLINICAL trials ,HUMAN research subjects ,COMMUNICABLE diseases ,MEDICAL protocols ,STAPHYLOCOCCAL diseases ,STATISTICAL sampling - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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