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.

主要研究者/项目负责人（最后，第一，中间）：Reddy，Jr.，鲍比 项目概要： 在美国，至少有30%的抗生素是不必要的。这显然是灾难性的 对人类未来的影响。败血症是美国第三大死亡原因， 每年死亡人数超过23万人。据报道，生存率每小时适当下降7.6% 治疗延迟。这种生存率的急剧下降导致了医院抗生素的大量处方 设置.这种行为背后的一个主要因素是缺乏快速的方法来确定是否 个体化的患者实际上将受益于抗生素的预期疗程。此外，如果一个过程 尽管选择了抗生素来施用，但尚不清楚如何优化抗生素的降级。 这导致了一种全面的抗生素方法，几乎每个有败血症可能性的患者都服用了抗生素 使用广谱抗生素，并保持这些抗生素的时间远远超过必要的时间。 降钙素原（PCT）近年来作为细菌和 病毒感染来自bioMerieux和Roche等公司的各种PCT检测试剂盒已收到510 k FDA的许可证，供医生用于优化抗生素的管理。此外，本发明还提供了一种方法， 全身炎症反应综合征（SIRS）标准通常用作全球炎症反应综合征的粗略指征。 患者的炎症问题。在这四个标准（WBC计数、呼吸率、心率和 由于白细胞计数在临床实验室之外是不可能测量的，因此，在临床实验室之外，仅白细胞计数是不可能测量的。手持设备 该联合收割机可以在10分钟内从一滴血中结合WBC计数和血浆PCT测量， 彻底改变急性护理环境中的抗生素管理。特别是，获得第一个 在到达急诊室之前尽早测量PCT和WBC是至关重要的。 理想情况下，这将通过最常见的“漏斗”进入急诊室，包括门诊病人， 门诊和疗养院设置。几项研究表明，这两个时间趋势 参数对于进一步调整所施用的抗生素是非常有力的。例如，Roche的 Elecsys BRAHMS PCT系统建议在第0天和第4天进行PCT测量， 这种差异应该被用于通知抗生素的优化。 ElectroCyt，Inc.是一家早期的公司，已经筹集了170万美元的投资， 伊利诺伊大学厄巴纳-香槟分校的技术。该公司的目标是开发一种手持 具有随附的盒设计管线的电子阅读器 表面受体表达水平和血浆蛋白表达水平。我们的第一个测试盒将测量 一滴血的白细胞计数和PCT。该公司签署了一项令人兴奋的联合开发协议 (JDA)与富士康互连技术公司（FIT）合作开发低成本的原型墨盒和手， 读者来信（附信）。此外，ElectroCyt还建立了两个临床合作伙伴关系， 医院进行临床研究（附信），以建立一个独特的组合生物标志物/EMR数据集。这 数据集，当与机器学习结合用于预测分析和患者的最新生物标志物时 读数将向医生提供关于患者的总体“免疫状态评分”的真实的时间反馈。这个分数 可用于个性化评估患者从脓毒症中恢复或未恢复的情况 事件，它可以帮助医生调整抗生素疗程与真实的时间反馈。在这个项目中，我们将 调整我们的核心技术，专注于细胞测量，以实现血浆蛋白测量， 好.此外，我们将继续进行临床研究，以建立独特的联合生物标志物+ EMR 三个临床中心的数据集，芝加哥大学主医院、卡尔基金会医院和圣骑士团 弗朗西斯（OSF）医院。