Rapid point-of-care diagnosis of wound infection

 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，成本负担超过500亿美元。据估计，至少三分之二的所有慢性伤口被生物膜形成细菌感染。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），占住院患者中所有HAI的31%。虽然在感染控制实践方面取得了进展，但SSI仍然是发病、住院时间延长和死亡以及人口经济负担增加的重要原因。因此，迫切需要快速和准确地诊断和治疗急性或慢性伤口中的感染，以帮助伤口本身的适当愈合。快速床旁（Point-of-Care，简称PART）病原体鉴定（ID）和抗菌药物敏感性测试（AST）可减少抗生素的滥用，加速病原体导向应用，避免抗生素处方不当。MetalloPharm正在开发一种创新的设备，将满足这些要求的一个有用的制药产品。具体目标是开发快速、低成本、易于使用的病原体ID和AST产品，为临床医生提供可操作的结果，以帮助在1小时内进行伤口感染诊断和治疗，其中执业医师的真实的时间数据的可用性将在抗生素治疗的选择和时机方面产生显著差异。该格式是一个简单的2步测试，涉及直接混合样品和长达1小时的等待期，以产生肉眼读取的是/否颜色变化（基于106 CFU阈值的是/否感染）。不需要培训或特殊仪器，也不需要菌落分离和培养物富集。预期结果。为临床医生提供伤口样本诊断的可操作结果，包括（1）1小时内的快速病原体ID;（2）伴随的AST读数。这些研究将为检测伤口样本中的细菌提供一种新颖实用的工具，特别是因为AST可以同时进行。这种潜在的创伤性诊断的新奇和高临床影响将在伤口感染和愈合的临床治疗中产生范式转变。

 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.