Rapid point-of-care diagnosis of wound infection

伤口感染的快速护理点诊断

基本信息

批准号：
9136372
负责人：
Ada S Cowan
金额：
$ 22.5万
依托单位：
METALLOPHARM, LLC
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-07-06 至 2017-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9136372
关键词：
Accident and Emergency department Accounting Acute Agreement Antibiotic Therapy Antibiotics Antimicrobial susceptibility Bacteria Biological Assay Biological Markers Buffers Cessation of life Characteristics Cleaved cell Clinical Clinical Treatment Color Data Detection Development Devices Diagnosis Diagnostic Dyes Economic Burden Environment Enzymes Evaluation Eye Goals Growth Healthcare Hospitalization Hospitals Hour Human Infection Infection Control Intensive Care Units Label Life Liquid substance Lung Methodology Methods Microbial Biofilms Morbidity - disease rate Operative Surgical Procedures Outcome Patients Peptide Hydrolases Performance Physicians Population Preparation Pseudomonas aeruginosa Public Health Reading Reporter Reproducibility Salts Sampling Sensitivity and Specificity Site Societies Specialist Specificity Specimen Staphylococcus aureus Step Tests Technology Temperature Testing Time Traction Training United States Vial device Visual Wound Healing Wound Infection accurate diagnosis base chronic wound cost design direct application field study innovation instrument instrumentation meetings novel pathogen point of care point-of-care diagnostics prototype public health relevance rapid diagnosis response success tool urinary wound

项目摘要

DESCRIPTION (provided by applicant): In the United States, chronic wounds represent a major public health burden on patients as well as the health care economy. Estimates put the number of chronic wounds cases at over 6.5 million, with a cost burden of over $50 billion. It is estimated that at least two thirds of all chronic wounds are infected with biofilm forming bacteria Recent studies also found that surgical site infections (SSIs) were the most common healthcare- associated infection (HAI), accounting for 31% of all HAIs among hospitalized patients. While advances have been made in infection control practices, SSIs remain a substantial cause of morbidity, prolonged hospitalization, and death and rising economic burdens on the human population. Therefore, there is a critical need for rapid and accurate diagnosis and treatment of the infection in acute or chronic wounds to aid in the proper healing of the wounds themselves. Rapid point-of-care (PoC) pathogen identification (ID) and antimicrobial susceptibility testing (AST) decrease indiscriminate antibiotic use and accelerate pathogen- directed application to avoid inappropriate prescription of antibiotics. MetalloPharm is developing an innovative device that will meet these requirements for a useful PoC product. The specific goal is to develop rapid, low cost, simple-to-use PoC pathogen ID and AST products that provide clinicians with actionable results to aid in wound infection diagnosis and treatment within 1 hour, where the availability of real time data for the practicing physician will make significant differences in th choice and timing of antibiotic treatment. The format is a simple 2-step test involving direct mixing of sample and up to a 1 h waiting period to yield a yes/no color change (Yes/No infection based on a 106 CFU threshold) that is read by the naked eye. There is no requirement for training or special instrumentation, and no need for colony isolation and culture enrichment. Expected Outcome. To provide clinicians with actionable results for wound sample diagnosis, with (1) a rapid PoC pathogen ID within 1 h; (2) an accompanying AST readout. These studies will result in a novel and practical tool for the detection of bacteria in wound samples, especiall because the AST can be performed concurrently. The novelty and high clinical impact of this potential PoC diagnostic will create a paradigm shift in the clinical treatment of wound infection and healing.

描述（由适用提供）：在美国，慢性伤口代表了对患者和医疗保健经济的主要公共卫生烧伤。估计使慢性伤口案件的数量超过650万，成本耗资超过500亿美元。据估计，所有慢性伤口中至少三分之二被生物膜形成细菌，最近的研究还发现，手术部位感染（SSIS）是最常见的医疗保健相关感染（HAI），占住院患者所有HAI的31％。尽管在感染控制实践方面取得了进步，但SSI仍然是发病率，长期住院以及死亡以及对人口的经济伯纳伦斯的增长的实质性原因。因此，迫切需要快速，准确的诊断和对急性或慢性伤口感染的治疗，以帮助胜利本身的适当康复。快速护理（POC）病原体鉴定（ID）和抗菌易感性测试（AST）减少了不加选择的抗生素使用，并加速了由病原体的施用，以避免不适当的抗生素处方。金属载体正在开发一种创新的设备，该设备将满足这些有用POC产品的要求。具体的目标是开发快速，低成本，易于使用的POC病原体ID和AST产品，可为临床医生提供可行的结果，以帮助在1小时内进行伤口感染的诊断和治疗，在1小时内，实践的实时数据可用于实践，可以在选择和抗生素治疗的时间上有显着差异。该格式是一项简单的2步测试，涉及样品直接混合和1小时的等待时间，以产生肉眼读取的是/否颜色变化（是/否基于106 CFU阈值的感染）。不需要培训或特殊仪器，也不需要裂解菌落和培养。预期结果。为临床医生提供可起作用的伤口样品诊断结果，（1）在1小时内具有快速的POC病原体ID；（2）参加AST读数。这些研究将导致一种新颖而实用的工具，用于检测伤口样品中的细菌，因为可以同时执行AST。这种潜在的POC诊断的新颖性和高临床影响将在伤口感染和愈合的临床治疗中会引起范式转移。