Reducing antimicrobial overuse through targeted therapy for patients with community-acquired pneumonia: a study protocol for a cluster-randomized factorial controlled trial (CARE-CAP).
Reducing antimicrobial overuse through targeted therapy for patients with community-acquired pneumonia: a study protocol for a cluster-randomized factorial controlled trial (CARE-CAP).
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社区获得性肺炎（CAP）是一个重要的公共卫生问题，也是美国住院和住院患者使用抗菌药物的主要原因。然而，确定病原体是具有挑战性的，因为传统的培养方法是缓慢和不敏感的，导致长时间的经验性治疗与超广谱抗生素（ESA），有助于增加住院时间和抗菌药物耐药性。减少暴露于ESA的两种潜在方法是（a）快速诊断测定，其可以在数小时内提供准确的结果，从而避免对经验性治疗的需要，以及（B）在临床稳定的患者中在阴性细菌培养后降级。我们将在克利夫兰诊所卫生系统的12家医院进行一项大型实用的2 × 2析因群集随机对照试验，该试验将测试这两种方法在成年CAP患者（年龄≥ 18岁）中减少ESA的使用。我们将入组超过12，000例患者，并评估入院时常规使用快速诊断检测和48小时后药剂师领导的降阶梯治疗对培养阴性的临床稳定患者与常规治疗的独立和联合作用。我们假设这两种方法都将减少ESA的天数。我们的主要结果是暴露于ESA治疗的持续时间，这是抗菌素耐药性的关键驱动因素。次要结局包括呼吸道病毒检测、抗病毒药物治疗、肺炎球菌尿抗原检测阳性、入院后72小时内降阶梯、降阶梯后再升阶梯至ESA、任何抗生素的总持续时间、14天住院死亡率、入院后转入重症监护室、医疗保健相关C.艰难梭菌感染、急性肾损伤、总住院费用和住院时间。我们的研究旨在确定早期识别病原体和药剂师领导的降级（呼吁注意阴性培养）是否可以安全地减少ESA在CAP患者中的使用。如果成功，我们的研究结果将导致更好的抗菌管理，以及改善患者的预后和降低医疗成本。我们的研究结果也可能为CAP的最佳管理提供临床指南。ClinicalTrials.gov NCT 05568654。于2022年10月4日注册。在线版本包含补充材料，可通过10.1186/s13063-023-07615-3获得。
Community-acquired pneumonia (CAP) is a significant public health concern and a leading cause of hospitalization and inpatient antimicrobial use in the USA. However, determining the etiologic pathogen is challenging because traditional culture methods are slow and insensitive, leading to prolonged empiric therapy with extended-spectrum antibiotics (ESA) that contributes to increased hospital length of stay, and antimicrobial resistance. Two potential ways to reduce the exposure to ESA are (a) rapid diagnostic assays that can provide accurate results within hours, obviating the need for empiric therapy, and (b) de-escalation following negative bacterial cultures in clinically stable patients. We will conduct a large pragmatic 2 × 2 factorial cluster-randomized controlled trial across 12 hospitals in the Cleveland Clinic Health System that will test these two approaches to reducing the use of ESA in adult patients (age ≥ 18 years) with CAP. We will enroll over 12,000 patients and evaluate the independent and combined effects of routine use of rapid diagnostic testing at admission and pharmacist-led de-escalation after 48 h for clinically stable patients with negative cultures vs usual care. We hypothesize that both approaches will reduce days on ESA. Our primary outcome is the duration of exposure to ESA therapy, a key driver of antimicrobial resistance. Secondary outcomes include detection of respiratory viruses, treatment with anti-viral medications, positive pneumococcal urinary antigen test, de-escalation by 72 h from admission, re-escalation to ESA after de-escalation, total duration of any antibiotic, 14-day in-hospital mortality, intensive care unit transfer after admission, healthcare-associated C. difficile infection, acute kidney injury, total inpatient cost, and hospital length-of-stay. Our study aims to determine whether identifying an etiological agent early and pharmacist-led de-escalation (calling attention to negative cultures) can safely reduce the use of ESA in patients with CAP. If successful, our findings should lead to better antimicrobial stewardship, as well as improved patient outcomes and reduced healthcare costs. Our findings may also inform clinical guidelines on the optimal management of CAP. ClinicalTrials.gov NCT05568654. Registered on October 4, 2022. The online version contains supplementary material available at 10.1186/s13063-023-07615-3.
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影响因子：
105.7
作者：
Campbell, MK;Elbourne, DR;Altman, DG
通讯作者：
Altman, DG
影响因子：
11.8
作者：
Ramirez, Julio A.;Wiemken, Timothy L.;Carrico, Ruth M.
通讯作者：
Carrico, Ruth M.
DOI：
10.1136/bmj.e7586
发表时间：
2013-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Chan AW;Tetzlaff JM;Gøtzsche PC;Altman DG;Mann H;Berlin JA;Dickersin K;Hróbjartsson A;Schulz KF;Parulekar WR;Krleza-Jeric K;Laupacis A;Moher D
通讯作者：
Moher D
影响因子：
2.7
作者：
Ding P;VanderWeele TJ;Robins JM
通讯作者：
Robins JM
影响因子：
3.1
作者：
Berger, Ariel;Edelsberg, John;Weber, David J.
通讯作者：
Weber, David J.