Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs
- Conditions
- Organ Failure, Multiple
- Interventions
- Diagnostic Test: FTIR results
- Registration Number
- NCT05872152
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
This study will assess the impact of FTIRS typing on the spread of ESBL-E in intensive care units
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 900
- Adult patients hospitalized in ICU
- ESBL-E carrier
- none
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Transmission of FTIR results FTIR results In second phase of the study, the result of FTIR typing of recovered ESBL-E isolates will be weekly transmitted to participating centers.
- Primary Outcome Measures
Name Time Method Post intervention frequency of ESBL-E cross transmission as assessed by WGS 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 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
- Secondary Outcome Measures
Name Time Method Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS Month 24 Negative predictive value
Specificity of FTIRS to diagnose cross transmissions compared to WGS Month 24 Specificity
Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS Month 24 Positive predictive value
Sensitivity of FTIRS to diagnose cross transmissions compared to WGS Month 24 Sensitivity