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临床试验/NCT04131569
NCT04131569Unknown不适用

Association of Gut Microbiota Diversity With Extended-spectrum Beta-lactamase Producing Enterobacteriales Fecal Carriage and Subsequent Infection in Intensive Care Unit: Microbe Study

University of Bordeaux1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Gut bacteriobiota diversity according to ESBL specie

研究概览

简要总结

Antimicrobial resistance is a major threat worldwide and extended-spectrum beta-lactamase producing Enterobacteriales (ESBL-E) are a leading cause because of their wide dissemination. Gut microbiota seems to be correlated with multi-drug resistant organism carriage. This study thus aims to analyse the correlation between gut microbiota, ESBL-E fecal carriage and subsequent infection.

详细描述

The rising antimicrobial resistance has led to more than 33,000 deaths in Europe in 2015. Among them, extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) are the most frequent in Europe and have disseminated both in the community and in healthcare settings. Some studies have suggested that microbiota could be different between multi-drug resistant organisms, with different relative abundances of some bacteria. One study focused on ESBL-E fecal carriers, but in the community, with Bacteroides uniformis being more abundant in ESBL-E non-carriers than carriers. As identification of species discriminating between ESBL-E fecal carriers and non-carriers could pave the way for the design of ESBL-E carriage eliminating probiotics, we aim to analyse the correlation between gut microbiota and ESBL-E fecal carriage.

Moreover, mechanisms in the link between ESBL-E fecal carriage and subsequent ESBL-E infection remain, so far, poorly understood and this study aims to provide a first insight in the involvement of gut microbiota in the link between colonization and infection.

研究设计

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

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

  • Patient above 18 year-old admitted to intensive care unit
  • ESBL-E fecal carriage according to current screening recommendations for ESBL-E carriage group
  • Feces quantity on rectal swab adequate for routine screening and microbiota analysis

排除标准

  • Guardianship, curatorship, or prisoners
  • No health insurance
  • No legal representative

结局指标

主要结局

Gut bacteriobiota diversity according to ESBL specie

时间窗: at positive screening

Comparison of gut bacteriobiota alpha diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers

次要结局

  • Gut mycobiota diversity according to ESBL specie(at positive screening)
  • Gut bacteriobiota and subsequent ESBL-E infection(at admission)
  • Bacteria and the absence of subsequent ESBL-E infection(at admission)
  • Fungi and the absence of subsequent ESBL-E infection(at admission)
  • fungi and the absence of ESBL E. coli fecal carriage(at admission)
  • Gut bacteriobiota diversity according to ESBL specie(at positive screening)
  • fungi and the absence of ESBL K. pneumoniae fecal carriage(at admission)
  • bacteria and the absence of ESBL K. pneumoniae fecal carriage(at admission)
  • bacteria and the absence of ESBL E. coli fecal carriage(at admission)
  • Gut mycobiota and subsequent ESBL-E infection(at admission)

研究者

发起方
University of Bordeaux
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Pauline Esteves

Doctor

University of Bordeaux

研究点 (1)

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