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Diagnostics via Rapid Enrichment, Identification, and Phenotypic Antibiotic Susceptibility Testing of Pathogens from Blood.

通过血液中病原体的快速富集、鉴定和表型抗生素敏感性测试进行诊断。

基本信息

批准号：
10393529
负责人：
Betty B Wu
金额：
$ 110.95万
依托单位：
TALIS BIOMEDICAL CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-05-11 至 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10393529
关键词：
Address American Antibiotic Resistance Antibiotic Therapy Antibiotic susceptibility Antibiotic-resistant organism Antibiotics Antimicrobial Resistance Antimicrobial susceptibility Area Bacterial Antibiotic Resistance Biological Assay Blood Blood specimen California Candida albicans Centers for Disease Control and Prevention (U.S.)Chemistry Chicago Clinical Communicable Diseases Consumption Detection Development Diagnosis Diagnostic Drug resistance Economic Burden Engineering Enterobacteriaceae FDA approved Genomics Gram-Negative Bacteria Gram-Positive Bacteria Growth Health Personnel Hour Human Industrialization Infection Institutes Institution Intellectual Property Investments Joints Label Letters Life Measures Medicine Metabolic Methodology Methods Molecular Biology Mutation Nucleic Acids Pathogen detection Persons Pharmaceutical Preparations Phenotype Predisposition Preparation Procedures Protocols documentation Publications Rapid diagnostics Reagent Reporting Research Resistance Resistance profile Resort Sampling Savings Sensitivity and Specificity Sepsis Structure Technology Testing Time Universities antimicrobial bacterial resistance base bioinformatics pipeline clinical development clinical diagnostics cost design diagnostic platform diagnostic technologies digital drug development experience fungus global health human pathogen innovation innovative technologies microbial multidisciplinary multiplex detection new technology pathogen pathogenic bacteria pathogenic microbe point of care point-of-care diagnostics product development rapid technique resistant strain response single molecule

项目摘要

PROJECT SUMMARY This project “Diagnostics via Rapid Enrichment, Identification, and Phenotypic Antibiotic Susceptibility Testing of Pathogens from Blood,” submitted under RFA-AI-17-014 “Partnerships for Development of Clinically Useful Diagnostics for Antimicrobial-Resistant Bacteria (R01)” will develop a rapid, sensitive, and specific diagnostic platform for the culture-independent identification and determination of antimicrobial susceptibility and/or resistance of bacterial pathogens. The indiscriminate use and misuse of antibiotics has led to an impending global health crisis: the development of widespread antibiotic resistance. Bloodstream infections (BSI) are particularly significant with respect to their clinical impact: Severe sepsis strikes more than one million Americans every year, and 15 to 30 percent of those people die. In the absence of a rapid and reliable antibiotic susceptibility test (AST), health care providers often resort to broad-spectrum antibiotics, further escalating the development of drug-resistant strains. Halting the emergence and spread of antibiotic resistant organisms and providing appropriate life-saving therapy requires point-of-care (POC) diagnostics that can rapidly measure the drug susceptibility of a pathogen directly from clinical samples, eliminating the lengthy current procedures that require microbial growth. This project addresses a critical unmet need for rapid diagnostics that can both identify and determine the antimicrobial resistance profile of microbial pathogens. To address this problem, we propose to develop a combination of highly innovative technologies to (1) concentrate viable, low-abundance pathogens directly from blood without a culture step; (2) demonstrate the compatibility of the enrichment technology with the rapid and specific multiplexed detection of pathogens; (3) validate the compatibility of enrichment with an innovative, digital method of determining phenotypic antibiotic susceptibility; and (4) demonstrate that the entire workflow of pathogen concentration, identification, and phenotypic antibiotic susceptibility testing can be achieved in under 2 hours directly from human blood. This multidisciplinary project will be carried out by a highly experienced industrial research team with outstanding academic and clinical collaborators, and will create a new paradigm in diagnosis and treatment of bloodstream infections directly from clinical samples at the point- of-care. Countless lives will be saved and the spread of antibiotic resistance will be halted.

项目摘要本项目“通过快速富集、鉴定和表型抗生素敏感性测试进行诊断根据RFA-AI-17-014“开发临床有用的抗生素耐药细菌诊断（R 01）”将开发一种快速，灵敏，特异的诊断方法，用于非培养物依赖性鉴定和确定抗菌药物敏感性的平台，和/或细菌病原体的抗性。滥用和滥用抗生素已经导致了即将到来的全球健康危机：广泛的抗生素耐药性的发展。血液感染（BSI）就其临床影响而言尤其重要：严重脓毒症的发病率超过100万，每年都有美国人死亡，其中15%到30%的人死亡。由于缺乏快速可靠的抗生素敏感性试验（AST），卫生保健提供者往往诉诸广谱抗生素，进一步加速抗药性菌株的发展。阻止抗生素耐药性的出现和传播生物体和提供适当的挽救生命的治疗需要床旁（POC）诊断，直接从临床样本中快速测量病原体的药物敏感性，目前的程序需要微生物生长。该项目解决了一个关键的未满足的需要，快速诊断，可以识别和确定微生物病原体的抗微生物剂耐药性概况。为了解决这个问题，我们建议制定一个高度创新的技术组合，以（1）直接从（2）证明富集技术与快速和病原体的特异性多重检测;（3）验证富集与创新的，确定表型抗生素敏感性的数字方法;以及（4）证明整个工作流程病原体浓度，鉴定和表型抗生素敏感性测试可以在 2小时内直接从人血中提取这一多学科项目将由一个高度经验丰富的工业研究团队与杰出的学术和临床合作者，并将创建一个直接从临床样本中诊断和治疗血流感染的新范例- 护理。无数的生命将被拯救，抗生素耐药性的传播将被阻止。