Rapid point-of-care diagnosis of wound infection

伤口感染的快速护理点诊断

• 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
• 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

 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(由申请人提供)：在美国，慢性伤口是患者和医疗保健经济的主要公共卫生负担。据估计，慢性伤口病例的数量超过650万例，费用负担超过500亿美元。据估计，至少有三分之二的慢性创面感染了生物被膜细菌。最近的研究还发现，手术部位感染(SSI)是最常见的医疗保健相关感染(HAI)，占住院患者HAI的31%。虽然在感染控制实践方面取得了进展，但性传播感染仍然是发病率、长期住院和死亡的重要原因，并增加了人类人口的经济负担。因此，迫切需要对急慢性创面的感染进行快速准确的诊断和治疗，以帮助创面本身的适当愈合。快速护理点(PoC)、病原体识别(ID)和抗菌素敏感性测试(AST)减少了滥用抗生素的情况，并加快了病原体定向应用，以避免抗生素的不当处方。金属制药公司正在开发一种创新设备，该设备将满足对有用的PoC产品的这些要求。具体目标是开发快速、低成本、易于使用的PoC病原体ID和AST产品，为临床医生提供可行的结果，以在1小时内帮助伤口感染诊断和治疗，其中执业医生的实时数据的可用性将对抗生素治疗的选择和时机产生重大影响。该格式是一种简单的两步测试，包括直接混合样品和长达1小时的等待期，以产生由肉眼读取的是/否颜色变化(是/否感染基于106CFU阈值)。不需要培训或特殊仪器，也不需要菌落隔离和培养浓缩。预期结果。为临床医生提供可操作的伤口样本诊断结果，(1)1小时内快速的PoC病原体ID；(2)伴随的AST读数。这些研究将为伤口样本中细菌的检测提供一种新的实用工具，特别是因为AST可以同时进行。这种潜在的POC诊断的新颖性和高度的临床影响将在伤口感染和愈合的临床治疗中创造一种范式转变。