A Randomized Clinical Trial to Prevent Recurrent CA-MRASA Infection

预防复发性 CA-MRASA 感染的随机临床试验

• 批准号: 7219310
• 负责人: LOREN G. MILLER
• 金额: $ 30万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2009-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7219310
• 关键词: clinical research; clinical trials; communicable disease control; communicable disease transmission; community; cooperative study; environmental contamination; health education; household; human subject; human therapy evaluation; methicillin resistant Staphylococcus aureus; microorganism disease chemotherapy; patient oriented research; relapse /recurrence; skin infection; clinical research; clinical trials; communicable disease control; communicable disease transmission; community; cooperative study; environmental contamination; health education; household; human subject; human therapy evaluation; methicillin resistant Staphylococcus aureus; microorganism disease chemotherapy; patient oriented research; relapse /recurrence; skin infection

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.

描述（由申请人提供）：金黄色葡萄球菌是无处不在的病原体，会引起皮肤，血液，肺部和其他身体部位的感染。以前非常罕见的社区获得的甲氧西林抗甲氧西林的金黄色葡萄球菌（CA-MRSA）现在通常发生在全球范围内。在包括南加州在内的许多地区，CA-MRSA是皮肤感染最常见的原因。 CA-MRSA菌株以其在封闭环境中传播并引起健康人的反复感染的能力而闻名。复发性CA-MRSA感染的治疗具有挑战性，最佳预防策略是不确定的。许多专家推荐局部局部剂量，以净化身体和/或前鼻孔。其他人则建议环境净化，以帮助控制家庭内部的复发和传播。但是，没有数据可以量化这些方法的功效和安全性。我们将进行一项多中心临床试验，以比较身体和环境非殖民化方案在预防CA-MRSA感染中的功效和安全性。研究人群将包括患有复发性CA-MRSA感染的人。这项调查将与研究人员与Kaiser Permanente Southern California的调查人员合作，并具有丰富的研究CA-MRSA感染的经验，这是一个大型健康维护组织，是使用电子病历的领导者。对于这项临床试验，所有受试者将在2 x 2的设计中随机分配以进行测试：1）洗必氨酸沐浴露以及鼻莫皮罗辛软膏与通常的护理，以及2）用乙醇喷雾剂和积极的洗涤和没有环境清洁的环境清洁。我们还将进行互补研究，包括研究干预措施在防止家庭成员感染的功效，对复发性CA-MRSA感染的建模和测量药物经济结局。我们还将检查定植和感染CA-MRSA菌株的应变相关性，以更好地了解家庭内的定植动态。我们的临床试验将使我们对非殖民化方案的益处的理解在预防A-MRSA感染方面的好处。此外，我们的研究将提高我们对复发性CA-MRSA感染的发病机理和范围的理解。