International Clinical Administrative Core

摘要：国际临床管理核心，杜克大学 钩端螺旋体病是一种常见的世界性人畜共患病，不成比例地影响低资源地区。的能力 容易和准确地区分钩端螺旋体病感染与其他急性发热性疾病（AFI）的挑战是 非特异性临床特征和缺乏用于床旁诊断的诊断工具。P01计划将 研究病原体与宿主的相互作用及发展新的诊断方法以改善钩端螺旋体病的检测 基于宿主对非严重和严重感染的免疫和分子反应模式。这项工作是在一个 翻译途径的最终目标是快速，低成本的AFI诊断平台，适用于低 资源设置和部署在护理点。为实现计划目标，建议 国际临床管理核心（临床核心）将发挥协调中心的作用， 向斯里兰卡（加勒）的3个全球外地办事处提供全面、集中的行政和临床支助， 尼加拉瓜（莱昂）和坦桑尼亚（莫希），以及促进国际和国内 合作机构，包括巴斯德研究所（法国巴黎）和其他计划项目。的 临床核心包括一个经验丰富的跨学科团队，将利用现有的行政 和临床基础设施，以管理核心的3个具体目标，包括1）建立共享协议， 国际网站和项目，并为网站活动提供行政支持; 2）建立一个 整合临床数据和生物储存库资源，以支持所有计划项目;以及3）促进 在国际现场研究中心开展操作活动，以确保稳健的研究入组、标本采集和 数据、参考标准测试以及病因学和疾病严重程度确定。国际临床 行政核心将位于杜克全球健康研究所的Hubert-Yeargan中心（HYC）， 全球健康。临床核心将由HYC执行董事Christopher Woods，MD， MPH（核心共同领导，行政领导）和科学的梅根E。Reller，MD，PhD，MPH（核心联合负责人， 诊断导联）。

Abstract: International Clinical Administrative Core, Duke University Leptospirosis is a common worldwide zoonosis that disproportionately affects low resource areas. The ability to readily and accurately discriminate leptospirosis infection from other acute febrile illness (AFI) is challenged by non-specific clinical features and absence of diagnostic tools for point-of care diagnosis. This P01 program will investigate pathogen-host interactions and develop new diagnostic tests to improve leptospirosis detection based on host immune and molecular response patterns to non-severe and severe infection. This work is on a translational pathway towards the ultimate goal of rapid, low-cost AFI diagnostic platforms appropriate for low resource settings and deployable at the point-of-care. To achieve the program objectives, the proposed International Clinical Administrative Core (Clinical Core) will serve a coordinating center function to provide comprehensive, centralized administrative and clinical support to 3 global field sites in Sri Lanka (Galle), Nicaragua (Leon), and Tanzania (Moshi), as well as to facilitate interactions between international and domestic partnering institutions including between the Pasteur Institute (Paris, France) and other program projects. The Clinical Core comprises an experienced, interdisciplinary team that will leverage already existing administrative and clinical infrastructure to manage the Core’s 3 specific aims including 1) to establish sharing agreements with international sites and program projects and provide administrative support for site activities; 2) to establish an integrated clinical data- and bio-repository resource to support all program projects; and 3) to facilitate operational activities at international field sites to assure robust study enrollment, collection of specimens and data, reference standard testing, and etiology and disease severity determination. The International Clinical Administrative Core will be located within the Duke Global Health Institute’s Hubert-Yeargan Center (HYC) for Global Health. The Clinical Core will be led administratively by HYC Executive Director Christopher Woods, MD, MPH (Core Co-Lead, Administrative Lead) and scientifically by Megan E. Reller, MD, PhD, MPH (Core Co-Lead, Diagnostic Lead).