An interventional study of FTIR results in Organ Failure, Multiple, sponsored by University Hospital, Caen. Recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Prevention
This study will assess the impact of FTIRS typing on the spread of ESBL-E in intensive care units
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.
193 studies on the registry are indexed under Multiple Organ Failure; 47 are open to participants now.
This study's planned enrollment of 900 is above the median of 88 across 90 interventional studies indexed under Multiple Organ Failure.
Browse Multiple Organ Failure studies →University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.
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Exclusion Criteria:
Standard care are defined by routine procedures implemented in each center to prevent and control the diffusion of MDR-E bacteria in ICUs. In the first period of the study, the frequency of cross transmission will be assessed by sequencing the first ESBL-E isolate in each carrier patients (first isolate of a given species)
In second phase of the study, the result of FTIR typing of recovered ESBL-E isolates will be weekly transmitted to participating centers.
Diagnostic Test: FTIR results
Weekly transmission of FTIRS typing of ESBL-E to centers
Baseline frequency of ESBL-E cross transmission as assessed by WGS
Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers
Time frame: Month 9 to Month 12 (depending on centers, stepped wedge design)
Post intervention frequency of ESBL-E cross transmission as assessed by WGS
Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers
Time frame: Month 24
Sensitivity of FTIRS to diagnose cross transmissions compared to WGS
Sensitivity
Time frame: Month 24
Specificity of FTIRS to diagnose cross transmissions compared to WGS
Specificity
Time frame: Month 24
Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS
Positive predictive value
Time frame: Month 24
Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS
Negative predictive value
Time frame: Month 24
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for Sep 2026, 31 months after the start.
Of 28 interventional studies with no phase under Multiple Organ Failure, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's planned 31 months is above that.
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