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 每年在美国导致超过270,000人死亡，败血病是对A的全身性炎症反应 血液感染（BSI）。 BSI的早期诊断和治疗表现出改善的患者 结局和减少住院时间。但是，目前接受的诊断方法需要血液 培养步骤不仅慢，而且在存在抗菌剂的情况下也表现出降低的敏感性 治疗。因此 开始。对于不含文化并提供的BSI的新诊断方法非常需要 整个护理过程中的微生物信息。 为了满足这种未满足的需求，HelixBind将利用其专有直接范围内的功能（即 无培养）平台，快速（电阻和病原体鉴定）评估微生物负载 响应抗菌干预的感染。快速/BSI，该系统的第一个测试，检测到 在3小时内直接从患者全血中直接识别BSI。将广泛的测试菜单与单个结合 CFUS/ML敏感性，该测试不会被多数菌感染或抗菌治疗所困扰。穿过 多项临床研究，该测定表明敏感性> 95％，每个测定特异性> 99.8％。 FDA将Rapid/BSI指定为突破设备。 由于该程序，将添加快速/BSI的准确评估微生物负载的能力。与此 能力到位，初始测试结果将为临床医生提供病原体鉴定以及一项措施 负载；感染严重程度的标记。合并，此信息将帮助临床医生进行源控制和 选择最合适的抗菌干预措施。然后，后续测量将允许临床医生 要衡量微生物清除率，这是患者康复的必要条件。除了直接，特定于患者的影响之外， 该计划将根据需要直接支持改进的抗菌剂管理以对抗的崛起 抗菌抗性病原体。 我们的具体目标，每个目标都具有可量化的可交付成果，旨在完成所有技术开发， 与我们的临床合作伙伴合作，系统验证，压力测试和临床验证。重点 这项研究将是验证我们创新方法的能力，为进一步的工作奠定了基础 旨在优化其在临床环境中的实施。在实现我们的具体目标时，我们将拥有 开发和证明是一种革命性的方法，用于识别，表征，监视和 治疗血液的侵入性感染。