Point of Care Device for Reducing Overuse of Antibiotics in Potentially Septic Hospital Populations

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Principal Investigator/Program Director (Last, first, middle): Reddy, Jr., Bobby Project Summary: At least 30 percent of antibiotics prescribed in the United States are unnecessary. This has obviously catastrophic implications for the future of humanity. Sepsis is the third leading cause of death in the United States with an annual toll of over 230,000 people. Survival rates have been reported to drop by 7.6% per hour appropriate treatment is delayed. This drastic drop in survival rate leads to vast over prescription of antibiotics in hospital settings. A dominant factor underlying this behavior is the lack of rapid methods to determine whether or not an individualized patient would actually benefit from the intended course of antibiotics. Furthermore, if a course of antibiotics are chosen to be administered, it is not clear how to optimize the de-escalation of the antibiotics. This results in a blanket antibiotics approach, where nearly every patient with even a possibility of sepsis is dosed with broad spectrum antibiotics and stays on these antibiotics for far longer than is necessary. Procalcitonin (PCT) has shown much promise in recent years as a potential discriminator between bacterial and viral infections. Various assays for PCT from company such as bioMerieux and Roche have received 510k clearance from the FDA for use by physicians in optimizing the administration of antibiotics. In addition, Systemic Inflammatory Response Syndrome (SIRS) criteria are often used as rough indications of a global inflammatory problem in patients. Of these four criteria (WBC count, respiratory rate, heart rate, and temperature), only the WBC count is not currently possible to measure outside of clinical labs. A handheld device that could combine both a WBC count and a plasma PCT measurement from a drop of blood in 10 minutes could revolutionize the administration of antibiotics in acute care settings. In particular, obtaining the first measurement of both PCT and WBC as early as possible before arrival to Emergency Departments is critical. Ideally this would be obtained in the most common “funnels” into the acute care EDs, including outpatient, ambulatory, and nursing home settings. Several studies have shown that the temporal trends of these two parameters can be very powerful for further adjustments to the administered antibiotics. For example, Roche’s Elecsys BRAHMS PCT system recommends that a PCT measurement is performed at both day 0 and day 4, and that the difference should be used to inform optimization of the antibiotics. ElectroCyt, Inc. is an early stage company that has raised $1.7M in investment and has licensed its core technology from University of Illinois at Urbana-Champaign. The company aims to develop a hand-held electronic reader with an accompanying pipeline of cartridge designs to measure a variety of cell counts, cell surface receptor expression levels, and plasma protein expression levels. Our first cartridge will measure a total WBC count and PCT from a drop of blood. The company has signed an exciting joint development agreement (JDA) with Foxconn Interconnect Technologies (FIT) to co-develop the low cost prototype cartridge and hand- held readers (letter attached). In addition, ElectroCyt has also established two clinical partnerships with hospitals to perform clinical studies (letters attached) to build a unique combined biomarker/EMR dataset. This dataset, when combined with machine learning for predictive analytics and the patient’s latest biomarker readings, will provide real time feedback to physicians as to a patient’s overall “immune state score”. This score could be used as individualized evaluation of how well a patient is recovering or not recovering from a septic event, which can help physicians adjust course of antibiotics with real time feedback. In this project, we will adapt our core technology, which has focused on cell measurements, to enable plasma protein measurements as well. In addition, we will continue to perform clinical studies to build the unique combined biomarker + EMR dataset at three clinical sites, University of Chicago Main Hospital, Carle Foundation Hospital and Order of Saint Francis (OSF) hospital.