Rapid Detection of Catheter Related Bacteraemia

描述（由申请人提供）：中心静脉置管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500万中心静脉导管，由于人口老龄化，这一数字预计还会上升。然而，使用中心静脉导管的主要风险是它可能导致菌血症。在中心静脉置管患者中，3-7%（每年15万~ 35万例）发生菌血症，其中10-20%（1.5万~ 7万例）死亡。除死亡率高外，每个严重菌血症病例的直接住院费用为28 000至40 000美元。

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.