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

用于减少潜在脓毒症医院人群过度使用抗生素的护理设备

• 批准号: 9410203
• 负责人: Bobby Reddy
• 金额: $ 15万
• 依托单位: PRENOSIS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2018-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9410203
• 关键词: Point; Care; Device; Reducing; Overuse

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.

首席研究员/计划主任（最后，第一，中间）：小雷迪，鲍比 项目摘要： 在美国开处方的抗生素中至少有30％是不必要的。这显然有灾难性的 对人类未来的影响。败血症是美国的第三大死亡原因 年度超过230,000人的年度损失。据报道，适当的生存率下降了7.6％ 治疗被延迟。生存率的这种急剧下降导致医院的大量抗生素处方 设置。这种行为的主要因素是缺乏快速方法来确定是否是否 个性化的患者实际上将受益于预期的抗生素疗程。此外，如果课程 选择用于给药的抗生素，目前尚不清楚如何优化抗生素的降低。 这导致了一种毯子抗生素方法，几乎​​每个患有败血症可能性的患者 具有广泛的抗生素，并且在这些抗生素上停留的时间远远超过了必要的时间。 近年来，降钙素（PCT）作为细菌和 病毒感染。 BioMerieux和Roche等公司的PCT的各种测定已获得510K FDA清除医生在优化抗生素给药时使用。此外， 全身性炎症反应综合征（SIRS）标准通常用作全局的粗略指示 患者的炎症问题。在这四个标准中（WBC计数，呼吸率，心率和 温度），目前仅无法在临床实验室外测量WBC计数。手持设备 这可以结合WBC计数和在10分钟内从一滴血液中进行的血浆PCT测量 彻底改变了急性护理环境中抗生素的管理。特别是获得第一个 在到达急诊部门之前，尽早对PCT和WBC进行测量至关重要。 理想情况下，这将在最常见的“ Funnels”中获得，包括门诊，包括门诊病人 卧床和护士家庭环境。几项研究表明，这两个研究的临时趋势 参数可能非常强大，以进一步调整管理抗生素。例如，罗氏 Elecsys Brahms PCT系统建议在第0和第4天进行PCT测量，并且 差异应用于告知抗生素的优化。 Electrocyt，Inc。是一家早期舞台公司，已筹集了170万美元的投资并已获得了核心许可 伊利诺伊大学Urbana-Champaign的技术。该公司旨在开发手持 电子读取器具有随附的墨盒设计管道，以测量各种细胞计数，细胞 表面受体表达水平和血浆蛋白表达水平。我们的第一个墨盒将总计 WBC从一滴血中计数和PCT。该公司已签署了令人兴奋的联合发展协议 （JDA）与Foxconn Interconnect Technologies（fit）一起共同开发低成本的原型墨盒和手工 - 持有读者（附有字母）。此外，电循环还与 进行临床研究的医院（附带的信件），以构建独特的合并生物标志物/EMR数据集。这 数据集与用于预测分析的机器学习和患者的最新生物标志物结合使用时 读数将为医生提供有关患者总体“免疫状态评分”的实时反馈。 可以用作对患者康复程度的个性化评估或不从化粪池中恢复 事件，可以帮助医生通过实时反馈来调整抗生素方案。在这个项目中，我们将 适应我们的核心技术，该技术专注于细胞测量，以使血浆蛋白测量值为 出色地。此外，我们将继续进行临床研究以构建独特的合并生物标志物 + EMR 在三个临床地点的数据集，芝加哥大学主要医院，卡尔基金会医院和圣徒命令 弗朗西斯（OSF）医院。