International Clinical Administrative Core

国际临床行政核心

• 批准号: 10643288
• 负责人: Megan Elizabeth Reller
• 金额: $ 32.24万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-16 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10643288
• 关键词: Acute; Affect; Agreement; Classification; Clinical; Clinical Data; Clinical Microbiology; Clinical Research; Collection; Communicable Diseases; Data; Detection; Diagnosis; Diagnostic; Diagnostic tests; Disease; Doctor of Philosophy; Domestic Partners; Enrollment; Ensure; Etiology; Fever; Gene Targeting; Genes; Genetic Transcription; Goals; Immune; Immune response; Infection; Inflammatory Response; Infrastructure; Institution; International; Invaded; Lead; Leptospira; Leptospirosis; Longitudinal cohort study; Molecular; Morbidity - disease rate; Nicaragua; Paris, France; Pathway interactions; Pattern; Peptides; Phagocytes; Program Research Project Grants; Protocols documentation; Reference Standards; Research; Research Infrastructure; Resource Sharing; Resource-limited setting; Resources; Sampling; Severities; Severity of illness; Shipping; Site; Sri Lanka; Standardization; Tanzania; Testing; Translational Research; Universities; Virulence; Virulence Factors; Work; biobank; biomarker development; clinical infrastructure; clinical research site; cost; data sharing; diagnostic platform; diagnostic tool; evidence base; experience; global health; improved; molecular marker; mortality; novel; novel diagnostics; pathogen; point of care; point-of-care diagnosis; predictive tools; programs; research study; response; sample collection; virulence gene

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).

摘要：杜克大学国际临床管理核心 钩端螺旋体病是一种常见的世界性人畜共患病，对低资源地区的影响不成比例。有能力 钩端螺旋体病感染与其他急性发热性疾病(AFI)的挑战在于 非特定的临床特征和缺乏诊断工具的护理点诊断。这个P01计划将 调查病原体与宿主的相互作用并开发新的诊断测试以改进钩端螺旋体病的检测 根据宿主对非严重和严重感染的免疫和分子反应模式。这项工作正在进行中 通向快速、低成本AFI诊断平台的最终目标的转换途径 资源设置，并可在护理点部署。为实现方案目标，拟议的 国际临床管理核心(Clinic Core)将发挥协调中心的职能，提供 向斯里兰卡(Galle)的3个全球外地站点提供全面、集中的行政和临床支助， 尼加拉瓜(里昂)和坦桑尼亚(摩西)，以及促进国际和国内的互动 合作机构包括巴斯德研究所(法国巴黎)和其他计划项目之间的合作。这个 临床核心由一个经验丰富的跨学科团队组成，该团队将利用现有的管理 和临床基础设施，以管理核心的3个具体目标，包括1)与 国际站点和方案项目，并为站点活动提供行政支持；2)建立 整合临床数据和生物信息库资源以支持所有计划项目；以及3)促进 在国际实地开展业务活动，以确保强劲的研究招生、标本收集和 数据、参考标准测试、病因学和疾病严重性确定。国际临床学会 行政核心将设在杜克全球卫生研究所的休伯特-耶尔根中心(HYC)内，用于 全球健康。临床核心将由HYC执行董事克里斯托弗·伍兹医学博士领导。 公共卫生硕士(核心共同领导，行政领导)和Megan E.Reller，医学博士，公共卫生公共卫生硕士(核心共同领导， 诊断线索)。