Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in ICUs

强化控制策略包括：1）通过报告前鼻孔和粪便或肛周区域的监测培养结果来识别MRSA或VRE定植的患者; 2）通用手套（在与患者或患者环境互动期间使用手套），直至患者出院或其监测培养结果显示其未定植MRSA或VRE（以先发生者为准）;以及3）在护理MRSA或VRE定植患者期间的接触预防措施（在与患者或患者环境相互作用期间使用手套和隔离衣）。标准护理包括适当的手部卫生（洗手或使用无水手部消毒剂）和使用标准预防措施（根据与粘膜、伤口和体液接触的相互作用需要使用手套和其他屏障），以及收集监测培养物，但不向这些研究中心报告结果。将通过在患者入住ICU时、此后每周一次以及从ICU出院时采集患者的鼻和粪便或肛周区域拭子进行监测培养。监测培养的结果将用于比较ICU中使用强化控制策略与仅使用标准治疗策略的MRSA和VRE定植率。 进度报告：这项研究是由国家过敏和传染病研究所（NIAID）支持的多中心试验，并通过细菌学和真菌学研究组进行，这是一个由NIAID资助的临床试验网络。在20家参与研究中心之一入住MICU、SICU或MICU/SICU的18岁及以上男性和女性患者有资格参加本研究。NIH临床中心为本方案提供微生物学支持，不直接接触患者。将参与研究中心的所有微生物学标本送至实验室医学部。标本经过处理并记录在BAMBU数据库中。除了为参与研究中心提供微生物学支持外，还正在进行几项子研究，根据培养结果测试MRSA和VRE的新型快速诊断工具。我们已入组20，059份患者标本，研究现已关闭。(Last登记日为2006年8月25日）。该研究仅开放用于继续数据分析。 主要终点分析显示： 1.在MRSA或VRE流行的ICU中，强化控制策略不能有效降低MRSA或VRE定植或感染的发生密度 2. VRE定植比MRSA定植更常见，无论是在入院时还是作为新的定植事件 3.监测培养最初确定了大多数受试者在ICU住院期间成为定植者&其中很大一部分在入院时定植 4.与标准控制策略ICU相比，加强控制策略ICU中的手卫生和屏障预防措施的使用不足以减少MRSA和VRE的传播

The intensive control strategy involves: 1) identifying patients who are colonized with MRSA or VRE by reporting the results of surveillance cultures of the anterior nares and stool or perianal area; 2) Universal Gloving (use of gloves during interactions with the patient or the patients environment) until the patients are discharged or their surveillance culture results show they are not colonized with MRSA or VRE (whichever happens first); and 3) Contact Precautions (use of gloves and gowns during interactions with the patient or the patients environment) during care of patients who are colonized with MRSA or VRE. Standard care involves proper hand hygiene (handwashing or use of a waterless hand antiseptic) and use of Standard Precautions (use of gloves and other barriers as needed for interactions involving contact with mucous membranes, wounds, and body fluids) and collection of surveillance cultures, but not reporting of results to these sites. The surveillance cultures will be performed by obtaining swabs of the nose and stool or perianal area from patients upon admission to the ICU, at weekly intervals thereafter, and upon discharge from the ICU. The results of the surveillance cultures will be used to compare the rate of colonization with MRSA and VRE in ICUs using the intensive control strategy with those that use standard care alone. Progress Report: This study is a multi-center trial supported by the National Institute of Allergy and Infectious Diseases (NIAID) and is conducted through the Bacteriology and Mycology Study Group, a clinical trials network funded by NIAID. Male and female patients, ages 18 and above, who are admitted to the MICU, SICU or MICU/SICU at one of the 20 participating sites are eligible for the study. The NIH Clinical Center provides the microbiology support for this protocol and has no direct patient contact. All microbiology specimens from participating sites are sent to the Department of Laboratory Medicine. The specimens are processed and recorded in the BAMBU database. In addition to providing microbiology support for the participating sites, several sub-studies are underway testing novel rapid diagnostic tools for MRSA and VRE against culture results. We have enrolled 20,059 patient specimens and the study is now closed. (Last day for enrollment was August 25, 2006). The study remains open for continued data analysis only. Analysis of the primary endpoint show: 1.Intensive control strategy was not effective in reducing the incidence density of colonization or infection with MRSA or VRE in ICUs in which these organisms were endemic 2. Colonization with VRE was more common than colonization with MRSA, both on admission and as a new colonization event 3. Surveillance cultures initially identified the majority of subjects who became colonized during their ICU stay & a substantial proportion of those colonized on admission 4. Hand hygiene & use of barrier precautions, as practiced in the intensive control strategy ICUs, were not sufficient to reduce the transmission of MRSA and VRE compared with the standard control strategy ICUs