Fluoroquinolone Restriction for the Prevention of C. difficile Infection (CDI)_the FIRST Trial.

氟喹诺酮类药物限制用于预防艰难梭菌感染 (CDI)_FIRST 试验。

• 批准号: 10165788
• 负责人: NASIA SAFDAR
• 金额: $ 49.8万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10165788
• 关键词: Fluoroquinolone; Restriction; Prevention; C.; difficile

Abstract Each year, Clostridium difficile infection (CDI) affects 453,000 Americans, causes 29,000 deaths, and leads to an estimated $4.8 billion in excess costs in acute care hospitals within the US. Effective infection control measures and antibiotic stewardship (AS) are fundamental to sustained control of CDI in healthcare settings. There is an urgent need to identify and implement AS strategies that specifically target CDI by focusing on reducing use of antibiotics highly associated with increased risk of CDI, such as fluoroquinolones (FQ). Preprescription authorization (PPA) and postprescription review with feedback are two core AS strategies. However, it is unclear 1) which AS strategies are most effective in reducing CDI specifically and 2) how to implement AS strategies effectively. Without addressing these critical gaps, CDI prevention will continue to lag. The objective of the proposed study is to evaluate the effectiveness and implementation of a FQ PPA as an AS strategy to target and prevent CDI, promote appropriate antibiotic use, and reduce the transmission of resistant bacteria. This will contribute to the long-term goal of reducing the burden of CDI, which is an essential step in improving the safety and quality of healthcare. FQ PPA is a particularly promising AS strategy to reduce CDI. Although FQs are one of the most frequently utilized classes of antibiotics in inpatient acute care facilities and are closely associated with risk for CDI, FQ usage has not been the focus of control efforts in endemic settings in the US. The proposed study will use an effectiveness-implementation hybrid type 2 design to simultaneously evaluate the efficacy of an FQ PPA intervention to reduce CDI as well as the key considerations for implementing such an intervention successfully. Intensive care units in acute care hospitals throughout Wisconsin will participate in this stepped wedge cluster randomized controlled trial. The specific aims for the proposed study are to: 1) determine the impact of a FQ PPA on hospital-onset and healthcare-associated CDI rates and other clinical outcomes compared with usual care; and 2) evaluate the implementation of FQ PPA using a systems engineering approach. For aim 1, electronic health record data will be used to evaluate the impact of the FQ PPA on hospital-onset and healthcare-associated CDI, as well as other important clinical outcomes. For aim 2, surveys and interviews with healthcare providers will be used to evaluate the contextual, implementation, and work system factors that contribute to successful implementation of a FQ PPA intervention. In addition to addressing an urgent need to identify effective AS strategies, this study will provide a framework to implement and evaluate other interventions for HAI prevention. Regardless of the results, the proposed study will generate data, tools and methods with widespread applicability for AS initiatives in healthcare-associated infection prevention.

抽象的 每年，艰难梭菌感染 (CDI) 影响 453,000 名美国人，导致 29,000 人死亡，并导致 据估计，美国急症护理医院的超额成本达 48 亿美元。有效的感染控制 措施和抗生素管理 (AS) 是医疗机构中持续控制 CDI 的基础。 迫切需要确定并实施专门针对 CDI 的 AS 战略，重点关注 减少使用与 CDI 风险增加高度相关的抗生素，例如氟喹诺酮类药物 (FQ)。 处方授权 (PPA) 和带反馈的处方后审查是两个核心 AS 策略。 然而，目前尚不清楚 1) 哪种 AS 策略在具体减少 CDI 方面最有效，以及 2) 如何 有效实施AS战略。如果不解决这些关键差距，CDI 预防将继续滞后。 拟议研究的目的是评估 FQ PPA 作为 AS 的有效性和实施情况 针对和预防 CDI、促进适当抗生素使用并减少耐药菌传播的策略 细菌。这将有助于实现减轻 CDI 负担的长期目标，这是实现这一目标的重要一步。 提高医疗保健的安全性和质量。 FQ PPA 是一种特别有前景的减少 CDI 的 AS 策略。 尽管 FQ 是住院急症护理机构中最常用的抗生素类别之一， 与 CDI 风险密切相关，FQ 的使用并不是流行地区控制工作的重点 在美国。拟议的研究将使用有效性实施混合类型 2 设计来同时 评估 FQ PPA 干预措施降低 CDI 的有效性以及关键考虑因素 成功实施此类干预。各地急症护理医院的重症监护室 威斯康星州将参加这项阶梯式楔形集群随机对照试验。具体目标为 拟议的研究旨在：1) 确定 FQ PPA 对医院发病和医疗保健相关 CDI 的影响 与常规护理相比的比率和其他临床结果； 2) 评估 FQ PPA 的实施情况 使用系统工程方法。对于目标 1，电子健康记录数据将用于评估 FQ PPA 对医院发病和医疗相关 CDI 以及其他重要临床的影响 结果。对于目标 2，将通过对医疗保健提供者的调查和访谈来评估背景、 有助于成功实施 FQ PPA 的实施和工作系统因素 干涉。除了满足确定有效 AS 策略的迫切需要之外，本研究还将提供 实施和评估其他预防医院感染的干预措施的框架。无论结果如何， 拟议的研究将生成广泛适用于 AS 倡议的数据、工具和方法 医疗保健相关感染预防。