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临床试验/NCT04903886
NCT04903886Unknown不适用

Epidemiology of ICU-acquired Infections in Patients With Fecal Carriage of Extended Spectrum Betalactamase Enterobacteriaceae (ESBL-E)

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
350
试验地点
1
主要终点
proportion of ESBL-E related infection in ICU-aquired infection

研究概览

简要总结

Worldwide emergence of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in ICU, with at least 10% of incidence at the admission in Europe. A systematic rectal swab is used in 70% of French ICU to detect intestinal ESBL-E carriage The relationship between intestinal carriage and ICU-acquired infection is not perfectly known. The investigators conducted a five years study monocentric retrospective observational cohort in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate which type of infections and which bacteria are involved.

The investigators also collect data about antibiotherapy used to treat these infections.

详细描述

Intestinal carriage of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in general population, morover in intensive care units. Systematic rectal swab for screening is done in 70% of French ICU in routine. Some studies had show a good negative predictive value of this test for ICU-acquired infection (for example ventilator-associated pneumoniae), but a poor predictive positive value. The precise relationship between intestinal carriage and ICU-acquired infection is not perfectly known.

Probabilist antibiotherapy with carbapenem for ESBL-E suspected infection are currently recommanded by national and european Guidelines, particulary in case of shock or immunodepression.

A ESBL-E systematic screening-guided strategy for probabilist antibiotherapy could be interesting, and could lead to a carbapenem or a carbapenem-sparing focused antibiotherapy.

The investigators conducted a monocentric retrospective observational cohort study in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate the number of ESBL-E related infections, the site of these infections and which species of bacteriae are involved. They also investigate which was the antibiotherapy administered, and investigate what factors lead clinicians to treat the infection with carbapenem antibiotherapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • admitted in Brest ICU (medical or surgical)
  • positive rectal swab for ESBL-Enterobacteriae screening at the admission or during the ICU stay
  • written consent

排除标准

  • refusing to participate

结局指标

主要结局

proportion of ESBL-E related infection in ICU-aquired infection

时间窗: 28 days

proportion of ESBL-E related infection in ICU-aquired infection

次要结局

  • mortality rate in ICU(28 days)
  • length of ICU-stay(28 days)
  • length of hospital-stay(28 days)
  • mortality in hospital(28 days)
  • use of carbapenem antibiotherapy(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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