The career development activities in this proposal will provide the principal investigator with the educational and practical experience in organizing and implementing clinical trials. The candidate has a proven commitment to clinical research, and will benefit from the research environment at Duke University. Ronald Goldberg MD is the primary mentor and his role as the principal investigator for the Neonatal Network at Duke University will provide a unique education in practical research experience for the candidate. John Perfect MD will serve as the second mentor bringing mycology and translational research expertise to the project as the Director of the Duke University Mycology Research Unit (DUMRU) funded by the NIH. Neonatal candidiasis is a lethal disease that is poorly understood. Despite an attributable mortality of 30%, the current standard for the diagnosis of neonatal candidiasis (repeated culture) has poor sensitivity. The proposal will link bench research in new diagnostic tests with clinical outcomes, develop risk stratification models, and propose plans for rapid diagnosis of neonatal candidiasis for clinicians with incomplete information. This Research Plan has been approved as a protocol by the Neonatal Network. The proposal will establish a prospective multi-center cohort of premature infants at high-risk for invasive candidiasis. This research will capitalize on the infrastructure of the Network to enroll infants, collect samples, and record clinical information so the candidate will acquire skills in leading multi-center collaborative research. It will rely on the DUMRU so that the candidate may complete the assays and the acquire tools in bench research. The specific aims are: 1) Evaluate three new diagnostic tests for invasive candidiasis (PCR, D/L arabinitol, and Beta-glucan assay). The sensitivity of each assay is expected to be 85%, 90%, and 85% respectively, and the specificity of each assay is expected to be approximately 85% 2) Develop a clinical model for risk-stratification based on clinical presentation, and 3) Prospectively test the performance of a predictive model against the clinical judgment of neonatologists. The proposal also includes a mentorship plan and a career development plan that will establish the PI as a successful, funded, independent investigator poised to conduct large-scale clinical trials in neonatal candidiasis.
NIH ExPorter
NIH ExPorter