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NCT05872152 | Not yet recruiting | Organ Failure, Multiple


Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs
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

Condition or disease

Organ Failure, Multiple

Intervention/treatment

FTIR results

Phase

Not Applicable

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.

Study Type : Interventional
Estimated Enrollment : 900 participants
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Fourier Transform Infrared Spectroscopy (FTIRS) on the Diffusion of ESBL Producing Enterobacterales in Intensive Care Units (ICU)
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 1, 2025
Arm Intervention/treatment

No Intervention: Standard care

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)

Experimental: Transmission of 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.

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Adult patients hospitalized in ICU
  • ESBL-E carrier
Exclusion Criteria
  • none

Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

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Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

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