Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection
Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection
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DOI：
10.1186/s13063-020-4102-0
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发表时间：
2020-02-12
期刊：
影响因子：
2.5
通讯作者：
Seifert, Harald
中科院分区：
文献类型：
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作者：
Kaasch, Achim J.;Rommerskirchen, Anna;Seifert, Harald
SABATO（金黄色葡萄球菌菌血症抗生素治疗方案）是一项随机、平行组、临床非劣效性试验，旨在研究早期口服转换治疗低风险金黄色葡萄球菌感染的有效性和安全性。最初的试验方案发表在Trials杂志上（访问地址：10.1186/s13063-015-0973-x）。在这里，我们描述研究方案的最终修订，并讨论其基本原理。方法/设计研究方案引入了三个主要变化：(1)改进了纳入和排除标准，使具有某些合并症（终末期肾脏疾病、严重肝脏疾病）和未感染异物（骨科假体、起搏器、植入式心脏转复除颤器）的患者在一定条件下符合入组条件；(2)降低目标样本量，选择常规的非劣效裕度为10%，并将中期分析（215例）转化为最终分析；(3)引入了30天后的额外随访，以便对患者进行更密切的随访。结论对研究方案进行了修改，以改善患者的入组和随访情况。此外，样本量的减少将有助于完成试验。
Background SABATO (Staphylococcus aureus bacteremia antibiotic treatment options) is a randomized, parallel-group, clinical non-inferiority trial designed to examine the efficacy and safety of early oral switch therapy in low-risk Staphylococcus aureus infection. The original trial protocol was published in Trials (accessible at 10.1186/s13063-015-0973-x). Here we describe final amendments to the study protocol and discuss the underlying rationale. Methods/design Three major changes were introduced into the study protocol: (1) the inclusion and exclusion criteria were refined so that patients with certain comorbidities (end-stage renal disease, severe liver disease) and uninfected foreign bodies (orthopedic prosthesis, pacemaker, implanted cardiac cardioverter-defibrillator) became eligible for enrollment under certain conditions; (2) the target sample size was decreased by choosing a conventional non-inferiority margin of 10% and converting the interim analysis (215 patients) into the final analysis; and (3) an additional follow-up visit after 30 days was introduced to allow for a closer follow-up of patients. Conclusion Changes to the study protocol were introduced to improve the enrollment and follow-up of patients. Furthermore, the decrease of the sample size will facilitate completion of the trial.