A Randomized Clinical Trial to Prevent Recurrent CA-MRASA Infection

描述（由申请人提供）：金黄色葡萄球菌是一种普遍存在的病原体，可引起皮肤、血液、肺部和其他身体部位的感染。社区获得性耐甲氧西林金黄色葡萄球菌（CA-MRSA）感染以前极为罕见，现在在世界范围内普遍发生。CA-MRSA是美国许多地区最常见的皮肤感染原因，包括南加州。CA-MRSA菌株因其在封闭环境中传播和在健康人群中引起复发性感染的能力而引人注目。复发CA-MRSA感染的管理具有挑战性，最佳预防策略尚不明确。许多专家建议局部用药去污身体和/或前鼻孔。其他人建议进行环境净化，以帮助控制复发和家庭内传播。然而，没有数据量化这些方法的有效性和安全性。我们将开展一项多中心临床试验，比较机体和环境去殖民化方案预防CA-MRSA感染的有效性和安全性。研究人群将包括患有复发CA-MRSA感染的人。这项调查将与南加州凯撒医疗机构（Kaiser Permanente Southern California）的研究人员合作，这些研究人员具有丰富的CA-MRSA感染研究经验。凯撒医疗机构是一家大型健康维护组织，在电子医疗记录的使用方面处于领先地位。在这项临床试验中，所有受试者将随机分为2 × 2设计，以测试：1)氯己定沐浴露加鼻用莫匹罗星软膏与常规护理，以及2)使用乙醇喷雾和积极洗涤的环境清洁与不进行环境清洁。我们还将进行补充调查，包括研究干预措施在预防家庭成员感染方面的功效，对CA-MRSA复发感染的预测因子进行建模，并测量药物经济学结果。我们还将研究定植和感染CA-MRSA菌株的菌株相关性，以更好地了解家庭内的定植动态。我们的临床试验将促进我们对非殖民化方案在预防A-MRSA感染方面的益处的理解。此外，我们的研究将促进我们对复发CA-MRSA感染的发病机制和范围的理解。

DESCRIPTION (provided by applicant): Staphylococcus aureus is a ubiquitous pathogen, and causes infections of the skin, bloodstream, lung, and other body sites. Community-acquired methicillin resistant S. aureus (CA-MRSA) infections, which were previously extremely rare, are now occurring commonly worldwide. CA-MRSA is the most common cause of skin infection in many locales in the U.S., including Southern California. CA-MRSA strains are notable for their ability to spread in closed settings and cause recurrent infections among healthy persons. Management of recurrent CA-MRSA infection is challenging and optimal prevention strategies are undefined. Many experts recommend topical agents that decontaminate the body and/or anterior nares. Others suggest environmental decontamination to help control recurrences and transmission within households. However, there are no data that quantify the efficacy and safety of these approaches. We will conduct a multi-center clinical trial to compare the efficacy and safety of body and environmental decolonization regimens in the prevention of CA-MRSA infection. The study population will comprise of persons suffering from recurrent CA-MRSA infection. This investigation will partner investigators with extensive experience studying CA-MRSA infection with investigators from Kaiser Permanente Southern California, a large Health Maintenance Organization that is a leader in the use of electronic medical records. For this clinical trial, all subjects will be randomized in a 2 x 2 design to test: 1) chlorhexidine body washes plus nasal mupirocin ointment vs. usual care, and 2) environmental cleansing with ethanol spray and aggressive laundering vs. no environmental cleansing. We will also conduct complementary investigations, including studying the interventions' efficacy at preventing infections in household members, modeling oredictors of recurrent CA-MRSA infection, and measuring pharmaco-economic outcomes. We will also examine strain relatedness of colonizing and infecting CA-MRSA strains to better understand colonization dynamics within households. Our clinical trial will forward our understanding of the benefit of decolonization regimens at preventing A-MRSA infection. Additionally, our studies will advance our understanding of the pathogenesis and scope of recurrent CA-MRSA infection.