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