International Clinical Administrative Core

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).