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.

首席调查员/项目总监(最后、第一、中间)：小雷迪，鲍比 项目总结： 在美国，至少30%的抗生素处方是不必要的。这显然是灾难性的 对人类未来的影响。脓毒症是美国第三大主要死亡原因， 每年死亡人数超过23万人。据报道，存活率每小时适当下降7.6% 治疗被推迟了。存活率的急剧下降导致医院大量过量开抗生素。 设置。这种行为背后的一个主要因素是缺乏快速方法来确定 个体化的患者实际上会从预期的抗生素疗程中受益。此外，如果一门课程 选择使用多种抗生素，目前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治疗方法，几乎所有有可能发生脓毒症的患者都会接受药物治疗。 使用广谱抗生素，并在这些抗生素上停留的时间远远超过必要的时间。 近年来，降钙素原(PCT)作为一种潜在的细菌性和非细菌性疾病的鉴别指标显示出很大的潜力。 病毒感染。BioMerieux和罗氏等公司对五氯苯酚的各种检测已经收到了510K FDA批准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)标准通常被用来作为全球 患者存在炎症问题。在这四项标准中(白细胞计数、呼吸频率、心率和 温度)，只有白细胞计数目前不可能在临床实验室外测量。一种手持设备 可以在10分钟内将一滴血的白细胞计数和血浆PCT测量结合起来，可以 改革急性护理环境中抗生素的管理。特别是，获得第一个 在到达急诊科之前尽早测量PCT和WBC是至关重要的。 理想情况下，这将通过最常见的“漏斗”进入急诊急诊室，包括门诊， 活动场所和疗养院环境。多项研究表明，这两者的时间趋势 参数对于进一步调整给药的抗生素可能是非常强大的。例如，罗氏的 Electrsys Brahms PCT系统建议在第0天和第4天都进行PCT测量，并且 这种差异应该被用来为优化抗生素提供信息。 ElectrCyt，Inc.是一家初创公司，已筹集了170万美元的投资，并已授权其核心 伊利诺伊大学香槟分校的技术。该公司的目标是开发一种手持式 电子阅读器，带有配套的盒式设计管道，用于测量各种细胞计数、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测量总容量 一滴血中的WBC计数和PCT。该公司签署了一份令人振奋的联合开发协议。 (JDA)与富士康互联技术公司(FIT)共同开发低成本原型墨盒和手提- 手持读者(随信附上)。此外，ElectrCyt还与以下公司建立了两个临床合作伙伴关系 医院进行临床研究(附信件)，以建立一个独特的组合生物标记物/EMR数据集。这 数据集，当与机器学习相结合时，用于预测性分析和患者的最新生物标志物 读数，将提供实时反馈给医生关于病人的整体“免疫状态评分”。这个比分 可用于对患者从败血症中恢复或未恢复情况的个体化评估 事件，可以帮助医生调整抗生素的疗程，并实时反馈。在这个项目中，我们将 采用我们专注于细胞测量的核心技术，使血浆蛋白质测量成为可能 井。此外，我们将继续进行临床研究，以建立独特的组合生物标志物+EMR 芝加哥大学主医院、卡尔基金会医院和圣公会三个临床站点的数据集 弗朗西斯(OSF)医院。