Rapid Detection of Catheter Related Bacteraemia

描述（由申请人提供）：中心静脉导管插入术是重症监护和癌症患者护理的重要组成部分。在美国，每年大约使用500万个中心静脉导管，而且由于人口老龄化，这个数字预计还会上升。然而，使用中心静脉导管的主要风险是它可能导致菌血症。在使用中心静脉导管的患者中，3-7%（每年150，000至350，000例）发生菌血症，其中10-20%（15，000至70，000例）是致命的。除了高死亡率外，每宗严重菌血症个案的直接住院费用为28，000至40，000元。 为了减少菌血症的发生率，一旦出现临床症状（例如，发热）与菌血症一致。由于临床标准（如发热）不是导管相关菌血症的可靠指标，因此只有一小部分（15%）取出的导管被证明是感染源或临床症状。由于导管重新插入和抗生素治疗，不必要的导管取出会带来额外的风险和成本。一个快速和准确的细菌测试，如一个假设在这里将是一个有用的工具，以帮助医生作出准确的决定，导管删除。我们建议使用我们的基于微粒的扩增（MBA）技术和一类新的细菌标记物来开发用于这种预期用途的细菌检测。MBA技术与新型细菌标记物一起使用时，应允许开发一种简单，廉价且高度敏感的测试。在本I期研究中，我们将通过（1）设计和制定检测方法，（2）优化检测方案，（3）评价检测方法的速度、特异性、灵敏度和定量能力，验证MBA技术用于检测导管相关菌血症的可行性。 该I期研究和后续II期研究的成功结果将导致该试验的商业化，这将有助于改善导管相关菌血症的前瞻性诊断，从而改善患者的健康。

DESCRIPTION (provided by applicant): Central venous catheterization is an essential part of intensive care and cancer patient care. Approximately 5 million central venous catheters are used each year in the U.S., and the number is expected to rise due to aging population. However, the major risk of using central venous catheters is that it can cause bacteraemia. Of the patients with central venous catheters, 3-7% (150,000 to 350,000 cases yearly) develop bacteraemia, of which 10-20% (15,000 to 70,000 cases) are fatal. In addition to high mortality rate, each severe bacteraemia case incurs $28,000 to 40,000 direct hospitalization cost. To reduce the incidence of bacteraemia, central venous catheters are often removed once a clinical symptom (e.g., fever) consistent with bacteraemia appears. Because clinical criteria such as fever are not reliable indicators for catheter related bacteraemia only a small fraction (15%) of the removed catheters are proven to be the source of infection or clinical symptoms. The unnecessary removal of catheter introduces additional risk and cost as a result of catheter reinsertion and antibiotic treatment. A rapid and accurate bacterial test such as the one postulated here would be a useful tool for aiding physicians in making accurate decisions on catheter removal. We propose to use our microparticle based amplification (MBA) technology and a novel class of bacterial markers to develop a bacterial test for such intended use. The MBA technology, when employed together with the novel class of bacterial markers, should permit the development of a test that is simple, inexpensive and yet highly sensitive. In this Phase I study, we will verify the feasibility of the MBA technology for use in detecting catheter related bacteraemia by (1) designing and formulating an assay, (2) optimizing the assay protocol, and (3) evaluating the assay performance in terms of its speed, specificity, sensitivity and quantitative capability. A successful outcome of this Phase I study and subsequent Phase II study will lead to commercialization of the test, which will contribute to the improvement of prospective diagnosis of catheter related bacteraemia and consequently the well being of patients.