Blood stream infections (BSIs) are a significant cause of morbidity and mortality in the USA. While the true incidence of nosocomial BSIs is unknown, several studies have reported that an estimated 250,000 cases occur annually. There is evidence to show that early and appropriate antimicrobial therapy is an important contributor to a favorable outcome for patients with BSI. Current diagnostic methods can take from 24 hours up to a week or more for positive pathogen identification and characterization. The reduction of the time period from specimen collection until the availability of species identification and antimicrobial susceptibility is therefore critical in improving outcomes for patients with severe bloodstream infections. No molecular diagnostic tool is currently available to clinical microbiology laboratories that have been validated against the existing gold standard methods for pathogen identification, and susceptibility testing. We plan to develop in close collaboration with bioMerieux, a global leader in clinical diagnostics, a next-generation nucleic acid based NASBA-Molecular Beacons platform for rapid identification of bacterial and fungal pathogens, and associated drug resistance in selected organisms. Three clinical sites in New York (USA), Toronto (CAN) and Manchester (UK) have been selected to evaluate the new platform in relation to an existing culturebased gold standard. These large tertiary care medical centers will create a robust environment to conduct the studies. They all provide complex intensive care services (greater than 300 beds total) to highly diverse at risk populations, have leading infectious diseases clinical researchers, and a clinical microbiology laboratory with the expertise and the experience necessary to conduct the evaluation. This comprehensive approach joining PHRI's technical expertise in molecular beacon probe development with bioMerieux NASBA technology and clinical diagnostic product development, along with outstanding clinical partners will help ensure that a product applicable to improving Sepsis outcome will emerge.
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