Decreasing Bioburden to Reduce Healthcare-Associated Infections and Readmissions

描述(由申请人提供)：医疗保健相关感染(HAI)是可预防的发病率和死亡率的主要原因。预防禽流感是国家患者的首要任务 安全性和最佳实践，因为它们的发病率、死亡率和成本都很高，每年导致超过65亿美元的医疗成本。大多数感染是由常见的细菌引起的，这些细菌通常生活在皮肤或鼻子里，由于侵入性医疗设备、手术切口或住院的生理影响，它们克服了身体的正常防御。重症监护病房(ICU)的研究表明，用洗必泰使患者皮肤非殖民化，用莫匹罗星使鼻孔非殖民化，可以预防许多HAI。然而，缺乏证据表明非殖民化在非ICU环境中的有效性，那里是大多数甲型HAI发生的地方，而且那里的医疗保健、感染风险、患者与患者之间的互动、病原体传播和洗澡做法与ICU环境有很大不同。因此，非殖民化在这些环境中很少使用，尽管它有可能显著降低人的健康保险比率。减少感染试验(在入院时处理Bioburden以消除感染)将有效地评估非殖民化对ICU外普通患者群体HAIS的影响。这项整群随机试验将随机选择50家医院，治疗近40万名患者，以评估1)每日普遍洗涤洗必泰以预防所有病原体感染，以及2)使用莫匹罗星鼻腔非殖民化治疗甲氧西林耐药金黄色葡萄球菌(MRSA)的已知携带者，MRSA是HAIS的最常见原因之一。虽然非殖民化在ICU等短期高危地区取得了成功，但这项试验将解决非ICU内科和外科病房中更大的医院感染问题。这些患者群体通常没有被评估，因为证明有效性的足够大的随机试验的复杂性和成本已经超出了传统的基于医院的试验的范围。这项试验将提供迫切需要的非殖民化评估，以减少几乎所有住院患者的医院感染风险和感染再入院。它将提供必要的信息，以确定仅在美国每年就有4000万住院患者通过每天用洗必泰洗澡来进行非殖民化的常规做法是否应该成为标准做法。或者，它将建议为这些ICU外的患者制定不同于ICU环境下有效的量身定做的策略。这项试验还将展示一种新的临床有效性研究模型的优势，该模型通过将研究嵌入到通常的医疗保健提供中，并利用大型医院系统的组织和信息学优势，快速有效地解决关键的管理问题。 公共卫生相关性：与医疗保健相关的感染是美国十大最常见的死亡原因之一，每年造成超过65亿美元的医疗费用。尽管大多数预防试验都集中在重症监护病房(ICU)，那里的日常感染风险最高，但大多数与医疗保健相关的感染发生在ICU之外。这项整群随机对照试验将评估用抗菌肥皂洗澡非ICU患者是否能预防与医疗保健相关的感染及其导致的再次住院。

DESCRIPTION (provided by applicant): Healthcare-associated infections (HAIs) are a leading cause of preventable morbidity and mortality. Prevention of HAIs is a national priority for patient safety and best practice because of their high morbidity, mortality, and cost, incurring over $6.5 billion dollars of healthcare costs each year. Most infections result from common bacteria that normally live on the skin or in the nose and which overcome the body's normal defenses because of invasive medical devices, surgical incisions, or the physiologic effects of hospitalization. Studies in intensive care units (ICUs) indicate that decolonization of patients' skin with chlorhexidine, and nares with mupirocin can prevent many HAIs. However, evidence is lacking about the effectiveness of decolonization in non-ICU settings, where the majority of HAIs occur, and where medical care, risk of infection, patient-to-patient interactions, pathogen transmission, and bathing practices differ considerably from ICU settings. Decolonization is thus rarely used in these settings, despite its potential to meaningfully decrease the HAI rate. The ABATE Infection Trial (Addressing Bioburden while Admitted To Eliminate Infection) will efficiently evaluate the impact of decolonization on HAIs in the general patient population outside ICUs. This cluster- randomized trial will randomize 50 hospitals treating nearly 400,000 patients to evaluate 1) universal daily chlorhexidine bathing to prevent infections from all pathogens, combined with 2) nasal decolonization with mupirocin for known carriers of methicillin-resistant Staphylococcus aureus (MRSA), one of the most common causes of HAIs. While decolonization has been successful in short-stay high risk areas, such as ICUs, this trial will address the much larger problem of HAIs in non-ICU medical and surgical wards. This patient population has typically not been evaluated because the complexity and cost of sufficiently large randomized trials to demonstrate effectiveness have been beyond the reach of conventional hospital-based trials. This trial will provide a critically needed evaluation of decolonization to reduce hospital infection risk and infectious readmissions in nearly all hospitalized patients. It will provide essential information to determine whether routine decolonization through daily bathing with chlorhexidine should become standard practice for 40 million patients hospitalized each year in the United States alone. Alternatively, it will suggest that tailored strategies distinct from those effective in ICU settings are needed for these patient outside ICUs. This trial will also illustrate the strengths of a new model of clinical effectivenes research that quickly and efficiently addresses critical management questions by embedding research into the usual delivery of health care, and using the organizational and informatics strengths of a large hospital system. PUBLIC HEALTH RELEVANCE: Healthcare-associated infections are one of the ten most frequent causes of death in the United States and incur over $6.5 billion dollars of healthcare costs each year. Although most prevention trials have focused on intensive care unit (ICUs), where the daily risk for infection is the highest, the majority of healthcare- associated infection occur outside of ICUs. This cluster-randomized controlled trial will evaluate whether bathing non-ICU patients with antimicrobial soap prevents healthcare-associated infections and the readmissions they cause.