权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection. Acronym: SABATO (Staphylococcus aureus Bacteremia Antibiotic Treatment Options)

低风险金黄色葡萄球菌血流感染的早期口服转换疗法。

基本信息

批准号：
217917502
负责人：
Professor Dr. Achim Kaasch
金额：
--
依托单位：
Institut für Medizinische Mikrobiologie und Krankenhaushygiene
依托单位国家：
德国
项目类别：
Clinical Trials
财政年份：
2012
资助国家：
德国
起止时间：
2011-12-31 至 2020-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/217917502?language=en
关键词：
Early oral switch therapy low

项目摘要

About 25,000 cases of Staphylococcus aureus bloodstream infections (SAB) occur annually in Germany. The standard antimicrobial therapy for uncomplicated SAB is at least 14 days of intravenously administered antimicrobials. Intravenous administration is thought to prevent SABrelated complications that result from dissemination to distant sites through the bloodstream. However, there is insufficient evidence that antimicrobial therapy needs to be administered intravenously. Patients with a very low risk for SAB-related complications may benefit from an early switch to oral antimicrobial therapy. Potential benefits are an earlier hospital discharge, fewer adverse reactions associated with intravenous therapy, increased quality of life, and cost savings.The SABATO study is a multicenter, open-label, randomized, controlled trial designed to demonstrate that an early switch from intravenous to oral antimicrobial administration is non-inferior to a conventional course of intravenous therapy. The primary endpoint is the rate of SAB-related complications (recurrent SAB or any culture confirmed deep-seated S. aureus infection) within 90 days in the per-protocol population. Secondary endpoints include clinical response to treatment, mortality, and length of hospitalization.The first patient was enrolled in Dec 2013. Until 31 January 2018, 3519 patients were screened in 36 study centers and 132 patients were enrolled into the trial. Despite considerable efforts, recruitment is behind schedule and obtaining the full sample size (430 patients) within an acceptable time period is out of reach. Therefore, we propose to stop recruitment in July 2019 when at least 50% of the full sample size (i.e. 215 patients) is enrolled. This adaptation has already been considered in the initial study protocol. The sample size will be sufficient to support a non-inferiority margin of 10%. This strategy will allow us to successfully complete the trial by December 2019.

德国每年大约发生2.5万例金黄色葡萄球菌血流感染(SAB)病例。对于无并发症的SAB，标准的抗菌治疗是静脉注射至少14天的抗菌药物。静脉给药被认为可以防止SAB相关的并发症，这些并发症是通过血液传播到远处的部位造成的。然而，没有足够的证据表明抗菌治疗需要静脉注射。SAB相关并发症风险非常低的患者可能受益于及早改用口服抗菌药物治疗。潜在的好处是更早的出院，与静脉治疗相关的不良反应更少，生活质量的提高，以及成本的节省。Sabato研究是一项多中心、开放标签、随机、对照试验，旨在证明早期从静脉注射改为口服抗菌药物治疗并不比传统的静脉治疗疗程差。主要终点是在符合方案的人群中90天内与SAB相关的并发症(复发的SAB或任何经培养证实的深层次金黄色葡萄球菌感染)的比率。次要终点包括对治疗的临床反应、死亡率和住院时间。首例患者于2013年12月入选。截至2018年1月31日，在36个研究中心对3519名患者进行了筛查，132名患者进入试验。尽管作出了相当大的努力，但招募工作落后于计划，在可接受的时间段内获得全部样本量(430名患者)是遥不可及的。因此，我们建议在2019年7月，当至少50%的全部样本(即215名患者)被纳入时，停止招募。这一适应已经在最初的研究议定书中得到考虑。样本量将足以支持10%的非劣势边际。这一战略将使我们能够在2019年12月之前成功完成试验。