BacterioScan — Department of Health and Human Services SBIR Phase I: NIAID

Description

PROJECT SUMMARY Bloodstream infectionsBSIsrepresent a very serious clinical manifestation that can be caused by a variety of bacterial and fungal pathogensmany of which have been associated with high rates of mortalityPhysicians caring for patients with BSIs are challenged with having very limited time to make an effective diagnosisincluding identification of the causative agent and determination of the antimicrobial susceptibility profile of that pathogenprompting the use of empiric treatment regimens that routinely consist of multiple broad spectrum antibioticsSince a comprehensive diagnosis typically takes several days to completemany patients receive antibiotics either unnecessarily or incorrectlydue to the lack of infection or infection with an antibiotic resistant pathogenrespectivelyAlthough currently unavoidable based on the diagnostic tools availablethese therapeutic decisions can have severely detrimental implications on patient healthincluding the generation of antibiotic resistant organisms and the destruction of normal bacterial florathe latter of which can give rise to additional downstream infections with pathogens such as Clostridium difficileWith these consequences in mindit is clear that new and improved processes that expedite the detection of BSI causing pathogens are vital to reducing patient mortality rates and enabling more effective antibiotic stewardship practicesThe proposed studies focus on developing a rapid and efficient method to detect BSIs directly from human whole bloodeffectively replacing standard blood culturing devices which can have extensive times to resultWe will evaluate commercially available blood separation devices for their sample processing effectiveness for subsequent analysis in the BacterioScanDxa highly sensitive laser light scattering device that has alog lower limit of detectionLODthan instruments currently used in clinical microbiology laboratoriesOnce establishedwe will use this process to determine the limit of detection and time topositivity for a broad panel of common BSI causing pathogenscomparing theDx s detection performance to that of a conventional blood culturing deviceBased on preliminary datawe anticipate significant improvements in times required to flag samples as positivewithout significant increases in pathogen LOD relative to currently utilized methodsLikewisewe envision a reduced time to definitively identify uninfected specimenspromoting the justified de escalation of unnecessary antimicrobial treatmentTaken togetherparticularly when considering the potentially dire clinical implications of BSIssuccessful execution of this proposal will empower clinicians to make faster and more informed therapy decisions whichin turnwill impact both patient care and the more prudent use of antimicrobial agents PROJECT NARRATIVE Current diagnostic tools for the detection of microbial bloodstream infectionsBSIssuffer from extended times to resultleading to unnecessary broad spectrum antimicrobial therapy and jeopardizing patient healthUtilizing our proprietary laser light scattering technologywe propose to expedite the BSI detection process to provide reliable results in a fraction of the time currently required in clinical practiceThis improvement will not only reduce the mortality rate associated with BSIsbut will also enable antibiotic stewardship practices in support of preserving our current antibiotic armamentarium