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是一种潜在的致命感染，需要长时间的抗生素治疗。目前，在接受IE手术瓣膜置换术治疗的患者中，关于术后抗生素的持续时间没有达成共识。尽管美国心脏协会（AHA）指南建议手术后最多6周的静脉注射抗生素，但这一建议是基于判断而不是公开的证据。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2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中提取的组织培养物显示没有病原体生长时。减少抗生素的使用对个体患者有几个潜在的好处，包括减少血管内导管和抗生素相关并发症，选择耐药细菌分离株，以及降低成本