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

在德国，每年大约发生25000例金黄色葡萄球菌血液感染（SAB）。无并发症SAB的标准抗菌治疗是至少14天静脉注射抗菌药物。静脉给药被认为可以防止sabb相关的并发症，这些并发症是由通过血液传播到远处的部位引起的。然而，没有足够的证据表明抗菌药物治疗需要静脉注射。sabb相关并发症风险极低的患者可能会从早期转向口服抗菌药物治疗中受益。潜在的好处是更早出院，减少与静脉注射治疗相关的不良反应，提高生活质量，并节省费用。SABATO研究是一项多中心、开放标签、随机对照试验，旨在证明从静脉注射到口服抗菌药物的早期转换并不比传统的静脉注射治疗过程差。主要终点是按方案人群90天内SAB相关并发症（复发性SAB或任何经培养证实的深部金黄色葡萄球菌感染）的发生率。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月入组。截至2018年1月31日，36个研究中心筛选了3519名患者，132名患者入组试验。尽管付出了巨大的努力，但招募工作仍落后于计划，无法在可接受的时间内获得全部样本量（430例患者）。因此，我们建议在2019年7月至少50%的全样本量（即215例患者）入组时停止招募。在最初的研究方案中已经考虑到了这种适应。样本量将足以支持10%的非劣效性裕度。这一战略将使我们能够在2019年12月之前成功完成试验。

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.