Develoment and clinical evaluation of a POC theranostic assay to inform therapy choice in Acute Respiratory Distress Syndrome

POC 治疗诊断测定的开发和临床评估，为急性呼吸窘迫综合征的治疗选择提供信息

• 批准号: 104639
• 金额: $ 148.68万
• 依托单位: RANDOX LABORATORIES LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=104639
• 关键词: Develoment; clinical; evaluation; POC; theranostic

"Acute Respiratory Distress Syndrome (ARDS) is a life threatening condition in critically ill patients, caused by infection or injury. Infection and injury induce inflammation in the lungs, causing the lungs to fill up with fluid thus preventing the normal movement of oxygen from the lungs to the blood, for distribution to the rest of the body. ARDS often progresses to further injury to other organs in the body, and is associated with high rates of mortality or long term disability in survivors.The incidence of ARDS is estimated to be 40,000 patients annually in the UK, 200,000 in the US and 3 million globally. Mortality rates range between 30-45%, depending on initial severity at diagnosis. There is no effective drug treatment for the condition despite numerous clinical trials to evaluate possible candidates. However, new evidence suggests that previously tried and discounted drugs may benefit certain patient sub-groups. Medical experts within our project consortium have found that ARDS patients with very high levels of certain markers of inflammation are more likely to respond to several therapies. Several biomarkers (substances we can measure in blood) have been identified to allow identification of these hyper-inflamed patients. This is the essence of stratified medicine, where a diagnostic test can inform individual therapy decisions, also known as theranostics. To allow rapid identification of the hyper-inflamed patient with ARDS, and hence guide the most effective therapy at the point of admission to Intensive Care Units, a near-patient theranostic test is required.Working with our clinical and academic partners, Randox have developed a test to identify hyper-inflamed ARDS patients and confirmed this works by testing over 120 blood samples. This project proposal will further develop this biomarker test to allow rapid near-patient analysis, using our new point of care (POC) diagnostic analyser. Once ready, our clinical / academic partners at Queen's University Belfast will co-ordinate a multi-centre clinical evaluation across Intensive Care Units in the UK to show that the test can be used at point of care to accurately stratify patients into hyper-inflamed and hypo-inflamed phenotypes (sub-groups). This will inform therapy decisions.The project thus aims to develop a theranostic ARDS test and prove that it is effective in identifying those critically ill patients that are more likely to respond to a tailored therapy."

“急性呼吸窘迫综合征（ARDS）是因感染或受伤引起的危重患者的生命危险状况。感染和损伤引起肺部炎症，导致肺部充满液体，从而填补液体，从而阻止氧气从肺部到血液的正常运动，以使其持续到持续的身体，以至于其他持续的疾病，以至于其他术语与其他人相关的疾病。在英国，ARDS的发病率每年为40,000名，在全球范围内，有3000万人的死亡率范围为30-45％。某些炎症标记很高的ARDS患者更有可能对几种疗法反应。已经鉴定出几种生物标志物（我们可以在血液中测量的物质），以识别这些超增强的患者。这是分层医学的本质，诊断测试可以为个人治疗决策提供信息，也称为治疗方法。为了快速鉴定ARDS的超炎症患者，因此需要在接受重症监护病房的入院时进行最有效的疗法，需要进行近乎患者的疗法测试。与我们的临床和学术伙伴一起工作，Randox开发了一项测试来鉴定超触及的ARDS患者，并通过120个血液样本进行了测试。该项目建议将进一步开发该生物标志物测试，以使用我们的新护理点（POC）诊断分析仪进行快速接近患者的分析。一旦准备就绪，我们在贝尔法斯特皇后大学的临床 /学术伙伴将在英国跨英国重症监护病房进行多中心临床评估，以表明该测试可以在护理上使用，以将患者准确地将患者分类为超增强的和超侵蚀的表型（子组）。因此，该项目旨在开发治疗疗法的ARDS测试，并证明其有效识别那些更有可能对量身定制疗法做出反应的重症患者。”