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临床试验/NCT03140410
NCT03140410Unknown不适用

Evaluation of the Emergence of the Resistance to Linezolid in Staphylococcus Epidermidis and Risk Factors Analysis : a Mono-centric Case-control Study

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2017年4月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
103
试验地点
1
主要终点
linezolid-resistance

研究概览

简要总结

Understanding the emergence of linezolid-resistance in Staphylococci has been allowed in the past years through the discovery of the clonal dissemination of a chromosomal cassette carrying a modified crf gene. New mutations have even been described. Though, clinical evidences are still lacking, especially concerning the factors associated to this emergence. It could seriously become quite problematic to eliminate one of the last therapeutic weapon at our disposal for the treatment of severe or complicated infections caused by resistant strains of Staphylococci and Enterococci.

We aim to describe the mechanisms that permitted to this resistance to become clinically significant, concerning meticillin-resistant Staphyloccocus epidermidis strains causing blood stream infections in ICU patients, and show the clinical risk factors associated with it through a case-control study on patients hospitalized in two ICUs of our hospital between 2011 and 2016.

详细描述

Resistance to linezolid has been increasing in the past years, suggesting growing therapeutic difficulties while narrowing the options for treating severe or complicated infections involving Staphyloccoci or Enterococci strains. This emergence has been partially explained after the discovery of chromosomal dissemination of a particular gene, named "crf", conferring high level resistance to oxazolidinones.

Moreover, this mechanism has been showed as being prevalent in several countries across North America, Asia, and Europe.

But still the link with clinical evidences has not yet been very well established.

In particular the role of S. epidermidis has become clinically significant concerning blood stream infections and catheter-linked infections. The reality of the pathogenicity is more widely accepted, especially regarding prosthetic joint infections, and immunocompromised patient, as in hematology and oncology.

Thus, it appears necessary to provide more solid informations concerning the risk of using this antibiotic in a high burden setting of resistance, where it might be prescribed intensively on critical situations, and thus responsible for a high selection pressure of resistance.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all adult patient admitted in ICU between april 2011 and october 2016, diagnosed for a blood stream infection during the ICU stay, whatever the antibiotic therapy conducted before or after the diagnosis

排除标准

  • minor-aged patients
  • less than 2 blood cultures positive
  • blood cultures distant from more than 48 hours
  • cultures positive to distinct pathogens

结局指标

主要结局

linezolid-resistance

时间窗: within the 28 days after diagnosis of blood stream infection, or identification of the first blood culture positive with S. epdermidis

searching for risk factors associated with blood stream infection due to a linezolid-resistant S.epidemridis strain

次要结局

  • mutations rate regarding crf gene(retrospective analysis, 1 to 5 years after blood stream infection diagnosis)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul-Henri WICKY

Medical Doctor

Centre Hospitalier Universitaire de Besancon

研究点 (1)

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