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临床试验/NCT02482051
NCT02482051已完成不适用

Ultra Rapid Culture Independent Detection of High-Priority Carbapenem Resistant Enterobacteriaceae Directly From Blood

Denver Health and Hospital Authority2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Bacteria identification

研究概览

简要总结

The purpose of this study is to develop a new and very rapid diagnostic test for identifying a certain type of bacteria called Enterobacteriaceae in blood. Rapid identification of bacteria will assist in decreasing the use of antibiotics and help more patients survive bacterial infections of the blood.

详细描述

It is our overall goal to develop a new diagnostic technology that will facilitate antibacterial stewardship to reduce selective pressure and improve patient outcomes. The Institute of Medicine has identified antibiotic resistance as one of the key microbial threats to health in the United States and has prioritized decreasing inappropriate use of antimicrobials as the primary solution to address this threat. The emergence of carbapenem resistance among Enterobacteriaceae (CRE) in the United States represents a recent and severe byproduct of excessive antimicrobial use with a high mortality rate in bacteremia. A major barrier toward decreasing use of antimicrobials is lack of sensitive and accurate rapid diagnostic tests for identifying bacterial etiologies of infection.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
7 Years 至 89 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Laboratory confirmed gram negative bacilli blood culture

排除标准

  • Pregnancy

结局指标

主要结局

Bacteria identification

时间窗: 3 hours

Accuracy of bacteria identification by the Accelerate ID/AST system compared to conventional microbiological methods of gram negative bacilli.

Accuracy of carbapenem susceptibility testing

时间窗: 3 hours

Accuracy of carbapenem susceptibility testing by the Accelerate ID/AST system compared to conventional microbiological methods of gram negative bacilli.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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