Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections
3rd generation cephalosporins (C3G) are the antibiotics recommended in probabilistic in most enteric infections in France including pyelonephritis and bacteraemia.
However, the prevalence of resistance of Enterobacteriaceae including E. coli to C3G is continuously increasing for several years. In 2012, in France, the proportion of E. resistant or intermediate coli categorized to C3G is 10 to 25% (EARSS data).
Antibiotics not adapted early in severe sepsis is responsible for worse prognosis for patients in terms of morbidity and mortality and unnecessary prolongation of the DMS.
At St. Joseph's Hospital on enterobacteria levels of resistance to C3G is 15.4%.
To avoid overuse of carbapenems for probabilistic antibiotic and to quickly prescribe antibiotics adapted to the resistance of the bacteria, it is interesting to use a rapid test for detection of resistance to C3G.
The Lacta ™ test could be used in this indication. This is a rapid test diagnostic orientation detecting hydrolysis of a substrate (chromogenic cephalosporin) by the enzymatic action of ESBL, cAMP-type cephalosporinases and carbapenemases. This test was initially marketed for rapid detection of resistance to C3G enterobacteria from isolated bacterial colonies in culture.
研究概览
地位
条件
详细说明
Main objective / secondary:
The investigators propose to conduct a study with a double objective:
- To assess the analytical performance and its positioning relative to all the tests available to us in urine samples,
- To evaluate prospectively the clinical impact test in urinary infections
Expected results and prospects:
This study will define the performance and limitations of this test in the most difficult situations (low number of bacteria / ml, haematic urine, ...) and will specify its indications and its place among all other tests before implanting it in our routine, as appropriate.
The clinical impact study will provide medical and economic analysis data including shortening time to adapt antibiotic therapies and put in septic isolation to argue the implementation of this test routinely.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ile-de-France
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Paris、Ile-de-France、法国、75014
- Groupe Hospitalier Paris Saint Joseph
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients may have a urinary infection ESBLE
- Patients accepting the use of their result for analysis.
Exclusion Criteria:
- No exclusion criteria
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
|---|
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A simple questionary filled
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of the relevance between antibiotic susceptibility and the antibiotic chosen,with phone questionary
大体时间：Hour 48
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The biologist advise, as usual, the physician about the antibiotic to choose at H0 according to the result of Beta Lacta™Test. After the first result given, the biologist ask, at hour 48,the physician about the antibiotic chosen and determine the relevance according to the antibiotic susceptibility. The answer can be yes or no. |
Hour 48
|
合作者和调查者
调查人员
- 首席研究员：Alban LE MONNIER, MD、Groupe Hospitalier Paris Saint Joseph
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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