Diagnostic tool for assessment and tracking of microbial load in bloodstream infections

用于评估和跟踪血流感染中微生物负荷的诊断工具

• 批准号: 10602029
• 负责人: Alon Singer
• 金额: $ 105万
• 依托单位: HELIXBIND, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-23 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10602029
• 关键词: Address; Antimicrobial Resistance; Assessment tool; Biological; Biological Assay; Blinded; Blood; Blood specimen; Breakthrough device; Budgets; Caring; Cessation of life; Clinical; Clinical Research; Collaborations; Combined Modality Therapy; Detection; Development; Diagnostic; Diagnostic tests; Dose; Early Diagnosis; Early treatment; Ensure; Exhibits; Hospitalization; Hospitals; Hour; Infection; Intervention; Lead; Leadership; Measurement; Measures; Medical center; Methods; Molecular Diagnostic Testing; Monitor; National Institute of Allergy and Infectious Disease; Outcome; Patient-Focused Outcomes; Patients; Performance; Preparation; Recovery; Research Design; Resistance; Sampling; Sepsis; Septicemia; Severities; Source; Specificity; Specimen; Stress Tests; System; Techniques; Technology; Test Result; Testing; Time; Treatment Effectiveness; Validation; Viral; Viral Load result; Whole Blood; Work; antimicrobial; clinical research site; combat; commercialization; cost; design; diagnostic strategy; diagnostic tool; follow-up; improved; in vivo; innovation; interest; member; microbial; novel diagnostics; optimal treatments; pathogen; pathogenic bacteria; pathogenic fungus; patient population; programs; response; standard of care; success; systemic inflammatory response; timeline; validation studies

PROJECT SUMMARY Leading to over 270,000 deaths in the US annually, septicemia is the systemic inflammatory response to a bloodstream infection (BSI). Early diagnosis and treatment of BSIs have demonstrated improved patient outcomes and reduced hospitalization time. However, currently accepted diagnostic approaches require a blood culturing step, which is not only slow, but also demonstrates reduced sensitivity in the presence of antimicrobial treatment. Current techniques are therefore considered unreliable for monitoring effectiveness of treatment once begun. There is a significant need for new diagnostic approaches for BSIs that are culture-free and provide microbiological information throughout the course of care. To address this unmet need, HelixBind will leverage the capabilities of its proprietary direct-from-specimen (i.e., culture-free) platform, RaPID (Resistance and Pathogen IDentification) to assess the microbial load of an infection in response to an antimicrobial intervention. RaPID/BSI, the first test for this system, detects and identifies BSIs directly from patient whole-blood within 3 hours. Incorporating a broad test menu with single CFUs/ml sensitivity, the test is not confounded by polymicrobial infections nor antimicrobial treatment. Across multiple clinical studies, the assay has demonstrated >95% sensitivity and >99.8% per assay specificity. RaPID/BSI was designated as a Breakthrough Device by the FDA. As a result of this program, the capability to accurately assess microbial load will be added RaPID/BSI. With this capability in place, initial test results will provide clinicians with pathogen identification along with a measure of load; a marker for infection severity. Combined, this information will assist clinicians in source control and selecting the most appropriate antimicrobial intervention. Follow-up measurements will then allow the clinician to gauge for microbial clearance, a requisite for patient recovery. Beyond the immediate, patient-specific impact, this program will directly support improved antimicrobial stewardship as required to combat the rise of antimicrobial resistance pathogens. Our Specific Aims, each with quantifiable deliverables, are designed to complete all technical development, systems verification, stress testing, and clinical validation in collaboration with our clinical partners. The focus of this study will be to validate the capability of our innovative approach, setting the stage for further work aimed at optimizing its implementation in the clinical setting. In achieving our Specific Aims, we will have developed and demonstrated, a revolutionary approach towards identifying, characterizing, monitoring, and treating invasive infections of the bloodstream.

项目摘要 败血症每年在美国导致超过270，000人死亡，败血症是对急性炎症的全身性炎症反应。 血液感染（BSI）。BSI的早期诊断和治疗已证明患者 结果和减少住院时间。然而，目前公认的诊断方法需要血液 培养步骤，其不仅缓慢，而且在抗微生物剂存在下显示出降低的敏感性。 治疗因此，目前的技术被认为是不可靠的监测治疗的有效性， 开始.因此，迫切需要一种新的无培养的BSI诊断方法， 在整个护理过程中提供微生物信息。 为了解决这一未满足的需求，HelixBind将利用其专有的直接从样本（即， 无培养）平台，RaPID（耐药性和病原体鉴定），以评估微生物负荷的一个 抗微生物药物干预后的感染。RaPID/BSI是该系统的第一个测试， 在3小时内直接从患者全血中识别BSI。使用单个测试菜单扩展广泛的测试菜单 CFU/ml灵敏度，该检测不受多种微生物感染或抗菌治疗的混淆。跨 在多项临床研究中，该测定已证明>95%的灵敏度和>99.8%的每个测定特异性。 RaPID/BSI被FDA指定为突破性器械。 作为该计划的结果，将增加RaPID/BSI准确评估微生物负荷的能力。与此 能力到位，初步测试结果将为临床医生提供病原体识别沿着措施 负荷;感染严重程度的标志。结合起来，这些信息将有助于临床医生进行源控制， 选择最合适的抗菌干预措施。后续测量将允许临床医生 以测量微生物清除率，这是病人康复的必要条件。除了直接的、针对患者的影响外， 该计划将直接支持改善抗菌剂管理，以应对 耐药性病原体。 我们的具体目标，每一个可量化的交付成果，旨在完成所有的技术开发， 与我们的临床合作伙伴合作进行系统验证、压力测试和临床验证。重点 这项研究的目的是验证我们创新方法的能力，为进一步的工作奠定基础 旨在优化其在临床环境中的实施。为了实现我们的具体目标，我们将 开发并展示了一种革命性的方法，用于识别、表征、监测和 治疗血流的侵入性感染。