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洗必泰与常规沐浴预防普通医疗和外科病房的多重耐药菌和全因血流感染(ABATE 感染试验):一项集群随机试验。

Chlorhexidine versus routine bathing to prevent multidrug-resistant organisms and all-cause bloodstream infections in general medical and surgical units (ABATE Infection trial): a cluster-randomised trial.

机构信息

Division of Infectious Diseases, University of California Irvine School of Medicine, Irvine, CA, USA.

Clinical Services Group, HCA Healthcare, Houston, TX, USA; Division of Infectious Diseases, Texas A&M College of Medicine, Houston, TX, USA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA.

出版信息

Lancet. 2019 Mar 23;393(10177):1205-1215. doi: 10.1016/S0140-6736(18)32593-5. Epub 2019 Mar 5.

Abstract

BACKGROUND

Universal skin and nasal decolonisation reduces multidrug-resistant pathogens and bloodstream infections in intensive care units. The effect of universal decolonisation on pathogens and infections in non-critical-care units is unknown. The aim of the ABATE Infection trial was to evaluate the use of chlorhexidine bathing in non-critical-care units, with an intervention similar to one that was found to reduce multidrug-resistant organisms and bacteraemia in intensive care units.

METHODS

The ABATE Infection (active bathing to eliminate infection) trial was a cluster-randomised trial of 53 hospitals comparing routine bathing to decolonisation with universal chlorhexidine and targeted nasal mupirocin in non-critical-care units. The trial was done in hospitals affiliated with HCA Healthcare and consisted of a 12-month baseline period from March 1, 2013, to Feb 28, 2014, a 2-month phase-in period from April 1, 2014, to May 31, 2014, and a 21-month intervention period from June 1, 2014, to Feb 29, 2016. Hospitals were randomised and their participating non-critical-care units assigned to either routine care or daily chlorhexidine bathing for all patients plus mupirocin for known methicillin-resistant Staphylococcus aureus (MRSA) carriers. The primary outcome was MRSA or vancomycin-resistant enterococcus clinical cultures attributed to participating units, measured in the unadjusted, intention-to-treat population as the HR for the intervention period versus the baseline period in the decolonisation group versus the HR in the routine care group. Proportional hazards models assessed differences in outcome reductions across groups, accounting for clustering within hospitals. This trial is registered with ClinicalTrials.gov, number NCT02063867.

FINDINGS

There were 189 081 patients in the baseline period and 339 902 patients (156 889 patients in the routine care group and 183 013 patients in the decolonisation group) in the intervention period across 194 non-critical-care units in 53 hospitals. For the primary outcome of unit-attributable MRSA-positive or VRE-positive clinical cultures (figure 2), the HR for the intervention period versus the baseline period was 0·79 (0·73-0·87) in the decolonisation group versus 0·87 (95% CI 0·79-0·95) in the routine care group. No difference was seen in the relative HRs (p=0·17). There were 25 (<1%) adverse events, all involving chlorhexidine, among 183 013 patients in units assigned to chlorhexidine, and none were reported for mupirocin.

INTERPRETATION

Decolonisation with universal chlorhexidine bathing and targeted mupirocin for MRSA carriers did not significantly reduce multidrug-resistant organisms in non-critical-care patients.

FUNDING

National Institutes of Health.

摘要

背景

在重症监护病房,进行全身皮肤和鼻腔去定植可减少耐多药病原体和血流感染。全身去定植对非重症监护病房病原体和感染的影响尚不清楚。ABATE 感染试验的目的是评估在非重症监护病房使用洗必泰沐浴,干预措施类似于在重症监护病房发现的可减少耐多药生物体和菌血症的措施。

方法

ABATE 感染(主动沐浴以消除感染)试验是一项多中心随机对照试验,比较了常规沐浴与非重症监护病房的全身氯己定去定植和目标性莫匹罗星鼻腔去定植的效果。该试验在 HCA 医疗保健附属的医院进行,包括从 2013 年 3 月 1 日至 2014 年 2 月 28 日的 12 个月基线期、从 2014 年 4 月 1 日至 5 月 31 日的 2 个月导入期和从 2014 年 6 月 1 日至 2016 年 2 月 29 日的 21 个月干预期。医院被随机分组,其参与的非重症监护病房被分配到常规护理或所有患者每天用洗必泰沐浴,对已知耐甲氧西林金黄色葡萄球菌(MRSA)携带者加用莫匹罗星。主要结局是归因于参与单位的 MRSA 或万古霉素耐药肠球菌临床培养,在未经调整的意向治疗人群中,以去定植组在干预期与基线期的 HR 与常规护理组的 HR 进行衡量。比例风险模型评估了各组之间结果减少的差异,考虑到了医院内的聚类。这项试验在 ClinicalTrials.gov 注册,编号为 NCT02063867。

结果

在基线期有 189081 例患者,在干预期有 339902 例患者(常规护理组 156889 例,去定植组 183013 例),涉及 53 家医院的 194 个非重症监护病房。对于单位归因性 MRSA 阳性或 VRE 阳性临床培养的主要结局(图 2),去定植组在干预期与基线期的 HR 为 0.79(0.73-0.87),常规护理组为 0.87(95%CI 0.79-0.95)。相对 HR 无差异(p=0.17)。在分配到氯己定的 183013 例患者中,有 25 例(<1%)不良事件与氯己定有关,均涉及氯己定,而莫匹罗星无报告。

解释

全身用洗必泰沐浴和针对耐甲氧西林金黄色葡萄球菌携带者的莫匹罗星目标性去定植并不能显著减少非重症监护病房耐多药病原体。

资金来源

美国国立卫生研究院。

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