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临床试验/NCT03338738
NCT03338738已完成不适用

Impact of Beta-lactams on the Microbiota and Relative Fecal Abundance of Multidrug Resistant Bacteria Ans Its Importance on Infectious Episodes in Hospitalized Patients

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年7月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
percentage of EBLSE

研究概览

简要总结

The global spread of ESBL-producing enterobacteria (EBLSE) poses a real public health problem. The exposure of patients to antibiotic therapy leads to an increase in resistant bacterial populations within the digestive flora. As a result, the diagnosis of digestive colonization by EBLSE is an event that has become common in hospitalized patients in intensive care / intensive care under high pressure antibiotics. The aim of this work is to study the impact of beta-lactams frequently prescribed on the microbiota and the emergence of multiresistant bacteria in the digestive flora and to evaluate, in colonized patients, the factors associated with the occurrence of an infectious episode. In particular, the impact of the relative fecal abundance of ESBL enterobacteriaceae on the occurrence of this event will be studied.

详细描述

Among enterobacteria, the production of ESBL is the first cause of multi-resistance. The consequences of multidrug-resistant enterobacterial infections predominantly represented by ESBLs are currently well known, both from the individual point of view (increase in mortality and length of hospital stay) and collective (increase in costs of care). Data from the literature reveal an increased risk of ESBL bacteremia in patients with rectal carriage of ESBL-producing enterobacteria. It therefore appears necessary in known patients with ESBL-producing enterobacteria to evaluate the impact of different antibiotics (beta-lactams) on the modification of flora, the increase of faecal abundance in multidrug-resistant bacteria such as E. coli ESBL and evaluate the factors associated with infections in these patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •ICU admitted patient
  • •rectal colonization of Enterobacteria
  • •accepting participation
  • •with medical insurance

排除标准

  • •patient without bacterial colonization
  • •under antibiotics more than 24hours
  • •without medical insurance

研究组 & 干预措施

Patients with ESBL, antibiotic pressure

Experimental

Patients with ESBL, antibiotic pressure will be included. On the day of inclusion, a stool culture is performed on the first stool issued after the start of antibiotic therapy in order to evaluate the initial flora and the relative initial faecal abundance of multidrug-resistant bacteria. In the absence of stool emission by the patient, a rectal swab will be performed. 72 hours after initiation of antibiotic therapy, a blood sample (5 ml) will be taken to determine plasma concentrations of antibiotics. In addition, a stool sample will be taken at 72 hours after the start of antibiotic therapy, at the end of antibiotic therapy and 60 days after this end to evaluate the change in initial flora and relative faecal abundance of ESBL-producing enterobacteria.

干预措施: Stool culture ans swab (Diagnostic Test)

结局指标

主要结局

percentage of EBLSE

时间窗: Day 60

ratio of number of colony of enterobacteria BLSE on number of total bacteria colony

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 (1)

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