跳至主要内容
临床试验/NCT05872152
NCT05872152招募中不适用

Impact of Fourier Transform Infrared Spectroscopy (FTIRS) on the Diffusion of ESBL Producing Enterobacterales in Intensive Care Units (ICU)

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2024年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
1
主要终点
Post intervention frequency of ESBL-E cross transmission as assessed by WGS

研究概览

简要总结

This study will assess the impact of FTIRS typing on the spread of ESBL-E in intensive care units

详细描述

Multidrug resistant enterobacterales (MDR-E) are a major threat for patients hospitalized in intensive care units (ICUs). To prevent MDR-E spread in ICUs, rectal swabs are routinely performed and cultured on selective media. However, bacterial identification and antimicrobial susceptibility results are not sufficient to diagnose cross transmissions. The gold standard technique is based on genomic analysis that require whole genome sequencing (WGS) of bacteria and followed by multilocus sequence typing (MLST) and Single Nucleotide Polymorphism (SNP) typing. This technology is rather expensive and not applicable in all centers.

Fourier Transform InfraRed Spectroscopy (FTIRS) is a developing method for rapid bacterial typing. This technology is simple and results can be obtained in one hour. It is therefore adapted to continuous surveillance of MDR-E. In France, extended spectrum betalactamase producing enterobacteriaceae (ESBL-E) represent the vast majority of MDR-E. We postulate that early diagnosis of cross-transmission by FTIRS may prevent the spread of ESBL-E in ICUs and favor compliance with hygiene measures. The aim of this study will be to assess the impact of systematic FTIRS typing of ESBL-E on ESBL-E cross-transmissions in ICUs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients hospitalized in ICU
  • ESBL-E carrier

排除标准

  • 未提供

结局指标

主要结局

Post intervention frequency of ESBL-E cross transmission as assessed by WGS

时间窗: Month 24

Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers

Baseline frequency of ESBL-E cross transmission as assessed by WGS

时间窗: Month 9 to Month 12 (depending on centers, stepped wedge design)

Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers

次要结局

  • Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS(Month 24)
  • Specificity of FTIRS to diagnose cross transmissions compared to WGS(Month 24)
  • Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS(Month 24)
  • Sensitivity of FTIRS to diagnose cross transmissions compared to WGS(Month 24)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验