Rapid Comprehensive Identification of Pneumonia Pathogens

肺炎病原菌快速综合鉴定

• 批准号: 8252951
• 负责人: RICHARD S AJIOKA
• 金额: $ 26.21万
• 依托单位: BIOFIRE DEFENSE, LLC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-15 至 2013-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8252951
• 关键词: Address; Adult; Antibiotics; Antimicrobial Resistance; Bacteria; Bronchial Tree; Cause of Death; Cessation of life; Child; Childhood; Clinical; Collection; Communities; Complex; Data; Detection; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic tests; Disease; Etiology; Evaluation; Failure; Gold; Health; Hour; Human; Idaho; Immunization; Individual; Influenza; Laboratories; Laboratory culture; Lead; Lower Respiratory Tract Infection; Lower respiratory tract structure; Methods; Molecular; Morbidity - disease rate; Nasopharynx; Organism; Outpatients; Pathogen detection; Patient Care; Patients; Pharyngeal structure; Pleural; Pneumonia; Population; Preparation; Quantitative Evaluations; Radiologic Finding; Relative (related person); Respiratory System; Respiratory tract structure; Sampling; Sensitivity and Specificity; Sepsis; Severity of illness; Site; Solutions; Specimen; Speed; Sterility; System; Technology; Testing; Therapeutic Agents; Time; United States; Upper respiratory tract; Viral; Virus; Walking; antimicrobial; base; burden of illness; clinical care; commercial application; cost; effective therapy; improved; innovation; instrument; intervention effect; mortality; novel therapeutics; pathogen; respiratory; respiratory virus; sample collection; technological innovation

DESCRIPTION (provided by applicant): Lower respiratory tract infections (LRTI), including pneumonia, are a significant threat to human health. For example, community-acquired pneumonia and influenza are together the seventh leading cause of death in the United States. There is a wide range of pathogens that can cause pneumonia. Defining the causative organism in pneumonia, however, is complex. Standard culture-based methods are slow and low-yield, therefore testing is often not performed. At the level of the individual patient, lack of an etioloic diagnosis can lead to the empiric and prolonged use of broad-spectrum antibiotics or to lack of effective therapy. At the population level, lack of a pathogen-based diagnosis decreases the ability to: a) accurately assess disease burden, b) evaluate the effects of interventions such as immunization, c) track antimicrobial resistance and d) investigate new therapeutic agents. Diagnosis of pneumonia would be greatly aided by rapid and comprehensive analysis of patient samples. Idaho Technology Inc. (ITI) manufactures rapid diagnostic products based on integrated PCR and detection technologies. The FilmArray platform is a fully-integrated automated system that performs sample preparation and target identification in one hour. The FilmArray, with its ease-of-use, short time-to-result and highly multiplexed pathogen panels is uniquely suited to the evaluation of both viral and bacterial agents of pneumonia. We propose to test two FilmArray panels, targeting respiratory pathogens and sepsis causing bacteria, on samples from patients with suspected pneumonia. Appropriate choice of site for respiratory collection is a complex question that will be addressed through analysis of several clinical sample types from both adult and pediatric patients (Specific Aim 1). The use of quantification may be beneficial in understanding the relative contribution of pathogens when more than one is detected (Specific Aim 2). At the end of this project, we will choose the most informative site and sample type to move forward toward development of a comprehensive diagnostic test with the potential to significantly improve the care of patients with pneumonia. PUBLIC HEALTH RELEVANCE: Challenges in diagnosing pneumonia include the large number of viruses and bacteria known to cause lower respiratory tract infections and slow and insensitive confirmation by culture. Idaho Technology's FilmArray platform is a fully-integrated automated system that performs sample preparation and identification of viral and bacterial pathogens in one hour. Existing FilmArray panels directed toward respiratory viruses and sepsis- causing bacteria will be modified to develop a comprehensive test to identify pneumonia pathogens.

描述（由申请人提供）：下呼吸道感染（LRTI），包括肺炎，对人类健康构成重大威胁。例如，社区获得性肺炎和流感一起成为美国第七大死因。可引起肺炎的病原体有很多种。然而，定义肺炎的致病微生物很复杂。标准的基于培养的方法速度慢且产量低，因此通常不进行测试。在个体患者层面，缺乏病因诊断可能导致经验性和长期使用广谱抗生素或缺乏有效的治疗。在人群层面，缺乏基于病原体的诊断会降低以下能力：a) 准确评估疾病负担，b) 评估免疫等干预措施的效果，c) 追踪抗菌药物耐药性，以及 d) 研究新治疗药物。对患者样本进行快速、全面的分析将极大地帮助肺炎的诊断。 Idaho Technology Inc. (ITI) 生产基于集成 PCR 和检测技术的快速诊断产品。 FilmArray 平台是一个完全集成的自动化系统，可在一小时内完成样品制备和目标识别。 FilmArray 具有易于使用、出结果时间短和高度多重病原体组合的特点，特别适合评估肺炎病毒和细菌病原体。我们建议在疑似肺炎患者的样本上测试两种针对呼吸道病原体和引起败血症的细菌的 FilmArray 面板。呼吸道采集地点的适当选择是一个复杂的问题，将通过分析成人和儿童患者的几种临床样本类型来解决（具体目标 1）。当检测到一种以上病原体时，使用定量可能有助于了解病原体的相对贡献（具体目标 2）。在该项目结束时，我们将选择信息最丰富的网站并 样本类型将有助于开发全面的诊断测试，有可能显着改善肺炎患者的护理。 公共卫生相关性：诊断肺炎的挑战包括已知会引起下呼吸道感染的大量病毒和细菌，以及培养确认缓慢且不敏感。 Idaho Technology 的 FilmArray 平台是一个完全集成的自动化系统，可在一小时内完成样品制备以及病毒和细菌病原体的识别。针对呼吸道病毒和引起败血症的细菌的现有 FilmArray 面板将进行修改，以开发一种全面的测试来识别肺炎病原体。