Efficacy and safety of 1.5% aqueous olanexidine gluconate antiseptic solution compared to 1% alcoholic chlorhexidine for the prevention of intravenous catheter-related infections (Apollo study): a protocol for a randomised controlled trial
Efficacy and safety of 1.5% aqueous olanexidine gluconate antiseptic solution compared to 1% alcoholic chlorhexidine for the prevention of intravenous catheter-related infections (Apollo study): a protocol for a randomised controlled trial
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DOI：
10.1136/bmjopen-2021-053925
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发表时间：
2021-12-30
期刊：
影响因子：
2.9
通讯作者：
Shime N
中科院分区：
文献类型：
--
作者：
Yasuda H;Kashiura M;Kishihara Y;Hifumi T;Abe T;Sasaki J;Moriya T;Morikane K;Shime N
目前建议在导管插入术前使用洗必泰酒精（1.0%–2.0%）作为皮肤消毒剂，以预防导管相关感染。但氯己定醇有多种副作用，且对耐甲氧西林金黄色葡萄球菌（MRSA）抗菌作用不大。因此，MRSA 仍然是预防导管相关血流感染 (CRBSI) 的一个问题。 Olanedine 含有 1.5% 葡萄糖酸奥兰西丁水溶液，于 2015 年在日本开发，结构与洗必泰相似。 Olanexine 已被用作针对各种革兰氏阳性和革兰氏阴性细菌以及 MRSA 的消毒剂。本研究旨在比较 1.5% 葡萄糖酸奥兰西丁水溶液和 1% 氯己定酒精作为皮肤消毒剂预防导管相关感染的功效。这项 Apollo 研究是一项开放标签、多中心、非劣效性、双臂、平行组、随机对照试验，在日本 21 个重症监护病房 (ICU) 和高级护理病房 (HCU) 中进行。所有计划入住参与本研究的机构的 ICU 或 HCU 且需要插入中心静脉导管的患者均符合资格。符合条件的患者将按 1:1 的比例随机分配至 1.5% 葡萄糖酸奥兰西丁水溶液组或 1% 洗必泰酒精组，并按中心分层。抗菌剂在导管放置之前和期间用作皮肤消毒剂。主要终点是导管相关感染的比例，定义为不伴菌血症的导管相关脓毒症和 CRBSI 的复合体。本研究共纳入 1980 名患者。本临床试验得到了济池医科大学机构审查委员会和参与机构伦理委员会的批准。研究结果将通过会议、同行评审出版物以及与感兴趣的各方举行的会议来传播。大学医院医疗信息网（注册ID：UMIN000042343）。该注册包括世界卫生组织试验注册数据集中的所有项目。该协议对应原始协议版本5。
Chlorhexidine alcohol (1.0%–2.0%) is currently recommended as a skin disinfectant to be used prior to catheterisation for preventing catheter-related infections. However, chlorhexidine alcohol has various side effects and has little antibacterial effect on methicillin-resistant Staphylococcus aureus (MRSA). Therefore, MRSA remains a concern for catheter-related bloodstream infection (CRBSI) prevention. Olanedine, containing 1.5% olanexidine gluconate in aqueous solution, was developed in Japan in 2015 and is structurally similar to chlorhexidine. Olanexine has been used as a disinfectant against various gram-positive and gram-negative bacteria and MRSA. This study aims to compare the efficacy of 1.5% aqueous olanexidine gluconate and 1% chlorhexidine alcohol as skin antiseptics for the prevention of catheter-related infections. This Apollo study is an open-label, multicentre, non-inferiority, two-arm, parallel-group, randomised controlled trial conducted at 21 intensive care units (ICUs) and high-care units (HCUs) in Japan. All patients scheduled to be admitted to the ICU or HCU of a facility participating in this study, who require central venous catheter insertion are eligible. Eligible patients will be assigned to either the 1.5% aqueous olanexidine gluconate or 1% chlorhexidine alcohol group by randomisation in a ratio of 1:1 with stratification by centres. The antibacterial agents are to be used as a skin disinfectant before and during catheter placement. The primary endpoint is the proportion of catheter-related infections, defined as a composite of catheter-related sepsis without bacteraemia and CRBSI. A total of 1980 patients will be included in this study. This clinical trial was approved by the Institutional Review Board of Jichi Medical University and the ethics committees of the participating institutions. The study results will be disseminated through conferences, peer-reviewed publications and meetings with interested parties. University hospital Medical Information Network (registration ID: UMIN000042343). This registration includes all items in the WHO Trial Registration Data Set. This protocol corresponds to the original protocol version 5.
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DOI：
10.1186/s13054-017-1890-z
发表时间：
2017-12-21
期刊：
Critical care (London, England)
影响因子：
--
作者：
Yasuda H;Sanui M;Abe T;Shime N;Komuro T;Hatakeyama J;Matsukubo S;Kawano S;Yamamoto H;Andoh K;Seo R;Inoue K;Noda E;Saito N;Nogami S;Okamoto K;Fuke R;Gushima Y;Kobayashi A;Takebayashi T;Lefor AK;for Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group
通讯作者：
for Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group
影响因子：
11.8
作者：
Rijnders, BJA;Van Wijngaerden, E;Peetermans, WE
通讯作者：
Peetermans, WE
影响因子：
120.7
作者：
Timsit, Jean-Francois;Schwebel, Carole;Lucet, Jean-Christophe
通讯作者：
Lucet, Jean-Christophe
影响因子：
3
作者：
Inoue, Yasuhide;Hagi, Akifumi;Iwata, Koushi
通讯作者：
Iwata, Koushi
DOI：
10.1186/cc8853
发表时间：
2010
期刊：
Critical care (London, England)
影响因子：
--
作者：
Frasca D;Dahyot-Fizelier C;Mimoz O
通讯作者：
Mimoz O