Optimizing duration of antibiotics after valve surgery for infective endocarditis

优化感染性心内膜炎瓣膜手术后抗生素的疗程

• 批准号: 8264280
• 负责人: VIVIAN H CHU
• 金额: $ 23.55万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-01 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8264280
• 关键词: Adverse event; American Heart Association; Antibiotic Resistance; Antibiotic Therapy; Antibiotics; Antimicrobial Resistance; Bacteremia; Cardiac; Cardiac Surgery procedures; Catheters; Cessation of life; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical trial protocol document; Cohort Studies; Collaborations; Conduct Clinical Trials; Consensus; Critiques; Data; Data Quality; Disease; Effectiveness; Endocarditis; Enrollment; Fostering; Goals; Growth; Guidelines; Incidence; Individual; Infection; Infective endocarditis; International; Intravenous; Judgment; Multi-Institutional Clinical Trial; Operative Surgical Procedures; Patients; Performance; Persons; Protocols documentation; Publishing; Randomized; Randomized Clinical Trials; Recommendation; Recruitment Activity; Relapse; Research; Research Institute; Research Personnel; Resources; Safety; Site; Surgical Valves; Time; antimicrobial; antimicrobial drug; bacterial resistance; base; cost; design; effective therapy; evidence base; experience; mortality; open label; pathogen; primary outcome; protocol development; secondary outcome; tissue culture; tool; trial comparing; valve replacement

DESCRIPTION (provided by applicant): IE is a potentially lethal infection requiring prolonged courses of antibiotic therapy. Currently, no consensus exists regarding duration of post-surgical antibiotics among patients undergoing surgical valve replacement for IE treatment. Although the American Heart Association (AHA) guidelines suggest up to 6 weeks of parenteral antibiotics following surgery, this recommendation is based on judgment rather than published evidence. By contrast, considerable evidence published subsequent to those guidelines now exists to suggest that 2 weeks of antibiotic therapy following valve surgery is as effective as longer courses of therapy, particularly when the tissue cultures taken from the valve at the time of surgery show no growth of the causative pathogen. A reduction in antibiotic use provides several potential advantages to the individual patient, including reductions in intravascular catheter and antibiotic-related complications, selection of resistant bacterial isolates, and costs related to extended courses of parenteral antibiotic therapy. In the current proposal we will design a multi- center, randomized clinical trial of patients who have undergone surgery for IE who will be randomized to usual treatment consisting of 6 weeks of antibiotic therapy versus a shortened 2 week course of antibiotic therapy. The primary outcome will be cure (absence of death or IE relapse) at 12 months; the secondary outcome will be adverse events related to antibiotic use and the use of intravascular catheters. The Specific Aims of the current proposal are to (1) develop the protocol and implementation tools for the clinical trial, and (2) recruit sies for participation in the clinical trial. We will accomplish these aims by leveraging the unique resources of the Duke Clinical Research Institute (DCRI), the world's largest academic clinical research organization and the International Collaboration on Endocarditis (ICE), a multinational network of investigators focused on research in IE. The overall goal of the proposed clinical trial is to demonstrate that the duration of antibiotic therapy can be reduced while maintaining effective treatment of IE. The results of this clinical trial will allow clinicians to make evidenc-based decisions regarding the duration of antibiotic therapy and will potentially reduce unnecessary antibiotic usage. PUBLIC HEALTH RELEVANCE: The overall goal of this study is to reduce antibiotic usage while maintaining effectiveness in treating IE. A shorter duration of antibiotic therapy for IE would impact patients on an individual level by potentially reducing antibiotic-related adverse events and reducing complications related to the intravascular catheters that are used to deliver parenteral antibiotics. From a societal perspective, a reduction in antibiotic usage has the potential to decrease selection of resistant bacterial isolates and to reduce costs related to prolonged intravenous antibiotic therapy.

描述（由申请人提供）：IE 是一种潜在致命的感染，需要长期的抗生素治疗。目前，对于接受外科瓣膜置换术治疗 IE 的患者术后抗生素持续时间尚无共识。尽管美国心脏协会 (AHA) 指南建议手术后最多使用 6 周的肠外抗生素，但该建议是基于判断而非已发表的证据。相比之下，在这些指南之后发表的大量证据表明，瓣膜手术后两周的抗生素治疗与较长疗程的治疗一样有效，特别是当手术时从瓣膜取出的组织培养物显示没有生长的情况下。致病病原体。抗生素使用的减少为个体患者提供了几个潜在的优势，包括减少血管内导管和抗生素相关并发症、耐药细菌分离株的选择以及成本 与延长肠外抗生素治疗疗程有关。在当前的提案中，我们将为接受 IE 手术的患者设计一项多中心、随机临床试验，这些患者将被随机分配接受常规治疗，包括 6 周的抗生素治疗与缩短的 2 周抗生素治疗疗程。主要结局是 12 个月时治愈（没有死亡或 IE 复发）；次要结果是与抗生素使用和血管内导管的使用相关的不良事件。当前提案的具体目标是（1）开发临床试验的方案和实施工具，以及（2）招募参与者参与临床试验。我们将利用世界上最大的学术临床研究组织杜克临床研究所 (DCRI) 和心内膜炎国际合作组织 (ICE) 的独特资源来实现这些目标，ICE 是一个专注于 IE 研究的跨国研究人员网络。拟议临床试验的总体目标 目的是证明可以在保持 IE 有效治疗的同时缩短抗生素治疗的持续时间。该临床试验的结果将使临床医生能够就抗生素治疗的持续时间做出基于证据的决定，并有可能减少不必要的抗生素使用。 公众健康相关性：本研究的总体目标是减少抗生素的使用，同时保持治疗 IE 的有效性。较短的 IE 抗生素治疗持续时间可能会减少与抗生素相关的不良事件，并减少与用于输送肠外抗生素的血管内导管相关的并发症，从而对患者个体产生影响。从社会角度来看，减少抗生素使用有可能减少耐药细菌分离株的选择，并降低与长期静脉注射抗生素治疗相关的成本。