A Randomized Clinical Trial to Prevent Recurrent CA-MRASA Infection

描述（由申请方提供）：金黄色葡萄球菌是一种普遍存在的病原体，可引起皮肤、血流、肺和其他身体部位的感染。社区获得性耐甲氧西林沙门氏菌。金黄色葡萄球菌（CA-MRSA）感染以前极为罕见，现在在全世界普遍发生。CA-MRSA是美国许多地区皮肤感染的最常见原因，包括南加州。CA-MRSA菌株以其在封闭环境中传播并在健康人群中引起复发性感染的能力而闻名。复发性CA-MRSA感染的管理具有挑战性，最佳预防策略尚未确定。许多专家建议局部药物，净化身体和/或前鼻孔。其他人建议消除环境污染，以帮助控制复发和家庭内的传播。然而，没有数据可以量化这些方法的有效性和安全性。我们将进行一项多中心临床试验，比较身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性CA-MRSA感染的人。这项调查将与研究CA-MRSA感染的丰富经验的调查人员合作，与来自Kaiser Permanente Southern加州的调查人员合作，Kaiser Permanente是一家大型健康维护组织，是使用电子病历的领导者。对于该临床试验，所有受试者将以2x2设计随机化以测试：1）氯己定沐浴露+鼻莫匹罗星软膏vs.常规护理，和2）使用乙醇喷雾和积极洗涤的环境清洁vs.无环境清洁。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有效性，建立CA-MRSA感染复发的预测因子模型，以及衡量药物经济学结果。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去殖民化方案在预防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性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.