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金黄色葡萄球菌菌血症中早期口服抗生素转换:金黄色葡萄球菌网络适应平台(SNAP)试验早期口服转换方案。

Early Oral Antibiotic Switch in Staphylococcus aureus Bacteraemia: The Staphylococcus aureus Network Adaptive Platform (SNAP) Trial Early Oral Switch Protocol.

机构信息

Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.

Department of Infectious Diseases University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.

出版信息

Clin Infect Dis. 2024 Oct 15;79(4):871-887. doi: 10.1093/cid/ciad666.

DOI:10.1093/cid/ciad666
PMID:37921609
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11478773/
Abstract

BACKGROUND

Staphylococcus aureus bloodstream infection (bacteremia) is traditionally treated with at least 2 weeks of intravenous (IV) antibiotics in adults, 3-7 days in children, and often longer for those with complicated disease. The current practice of treating S. aureus bacteremia (SAB) with prolonged IV antibiotics (rather than oral antibiotics) is based on historical observational research and expert opinion. Prolonged IV antibiotic therapy has significant disadvantages for patients and healthcare systems, and there is growing interest in whether a switch to oral antibiotics following an initial period of IV therapy is a safe alternative for clinically stable patients.

PROTOCOL

The early oral switch (EOS) domain of the S. aureus Network Adaptive Platform (SNAP) trial will assess early switch to oral antibiotics compared with continued IV treatment in clinically stable patients with SAB. The primary endpoint is 90-day all-cause mortality. Hospitalised SAB patients are assessed at platform day 7 ±2 (uncomplicated SAB) and day 14 ±2 (complicated SAB) to determine their eligibility for randomization to EOS (intervention) or continued IV treatment (current standard of care).

DISCUSSION

Recruitment is occurring in the EOS domain of the SNAP trial. As of August 2023, 21% of all SNAP participants had been randomized to the EOS domain, a total of 264 participants across 77 centers, with an aim to recruit at least 1000 participants. We describe challenges and facilitators to enrolment in this domain to aid those planning similar trials.

摘要

背景

金黄色葡萄球菌血流感染(菌血症)传统上在成人中使用至少 2 周的静脉(IV)抗生素治疗,在儿童中使用 3-7 天,对于患有复杂疾病的患者通常需要更长时间。目前,金黄色葡萄球菌菌血症(SAB)采用延长 IV 抗生素(而非口服抗生素)治疗的做法是基于历史观察性研究和专家意见。延长 IV 抗生素治疗对患者和医疗系统有重大不利影响,越来越多的人关注在初始 IV 治疗后是否可以安全地改用口服抗生素作为临床稳定患者的替代方案。

方案

金黄色葡萄球菌网络自适应平台(SNAP)试验的早期口服转换(EOS)域将评估在临床稳定的 SAB 患者中,与继续 IV 治疗相比,早期转换为口服抗生素的安全性。主要终点是 90 天全因死亡率。入院 SAB 患者在平台日 7 ±2(无并发症 SAB)和 14 ±2(有并发症 SAB)进行评估,以确定他们是否有资格随机分配到 EOS(干预)或继续 IV 治疗(当前的标准治疗)。

讨论

SNAP 试验的 EOS 域正在进行招募。截至 2023 年 8 月,SNAP 参与者中有 21%被随机分配到 EOS 域,共有 77 个中心的 264 名参与者,目标是招募至少 1000 名参与者。我们描述了该域中入组的挑战和促进因素,以帮助那些计划类似试验的人。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b560/11478773/e10846a15427/ciad666f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b560/11478773/e10846a15427/ciad666f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b560/11478773/e10846a15427/ciad666f1.jpg

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