Molecular Diagnostic Tools for Patient Oriented Field Studies in Infectious Disea

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DESCRIPTION (provided by applicant): I am a Clinician Investigator in the Division of Infectious Diseases at University of Virginia and am submitting this revised K24 proposal to move my research more deeply into patient oriented research (POR) and to provide protected time to mentor such trainees. In the 11 years since completion of ID fellowship I have developed a research program in several domains of tropical infectious diseases, now largely focused on the development of molecular diagnostic tools. Currently funded work includes a panel of assays to screen for the wide array of potential enteropathogens (Gates Foundation) and a PCR-based susceptibility test for second line drugs against MDR Tuberculosis (R01). With mature molecular diagnostics and collaborative clinical sites in place, now is an opportune time for this K24 to take these diagnostics to carefully designed POR studies in order to inform clinically important areas such as the cause of diarrhea in developing countries and proper treatment for MDR Tb. Specific Aims include (1) using our molecular diagnostics on enteropathogens, collaborations with field sites, and a range of statistical methods (odds ratios, quantitative loads, and prospective analysis) and intervention studies to infer what are the major pathogens associated with childhood diarrhea in developing countries and (2) using our molecular Tuberculosis drug susceptibility tests and collaborations with MDR Tb field sites to quantify improvements in drug susceptibility turnaround time and time-to-active MDR Tb regimen. This grant will allow me to gain needed training in elements of POR including clinical trial design and longitudinal biostatistics and will offer much-needed protected time for mentoring ID fellows and junior faculty in the Division and beyond. Furthermore I propose to use the program created by this K24 and my role as Vice-Chair for Research to bring together Departments of Medicine, Public Health Sciences, and Pediatrics as a platform for improvements in POR mentoring across the School.