Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
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, Staphylococcus aureus Network Adaptive Platform (SNAP) Study Group
Аннотация
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.