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Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05872152
Acronym
ECLA'IR
Enrollment
900
Registered
2023-05-24
Start date
2024-01-08
Completion date
2026-09-01
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organ Failure, Multiple

Keywords

multidrug resistant bacteria, outbreak, prevention and infection control, bacterial typing, Fourier transform infrared spectroscopy

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.

Interventions

DIAGNOSTIC_TESTFTIR results

Weekly transmission of FTIRS typing of ESBL-E to centers

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Stepped-wedge

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients hospitalized in ICU * ESBL-E carrier

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Baseline frequency of ESBL-E cross transmission as assessed by WGSMonth 9 to Month 12 (depending on centers, stepped wedge design)Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers
Post intervention frequency of ESBL-E cross transmission as assessed by WGSMonth 24Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers

Secondary

MeasureTime frameDescription
Sensitivity of FTIRS to diagnose cross transmissions compared to WGSMonth 24Sensitivity
Specificity of FTIRS to diagnose cross transmissions compared to WGSMonth 24Specificity
Positive predictive value of FTIRS to diagnose cross transmissions compared to WGSMonth 24Positive predictive value
Negative predictive value of FTIRS to diagnose cross transmissions compared to WGSMonth 24Negative predictive value

Countries

France

Contacts

Primary ContactCamille Jeanne-Leroyer
jeanneleroyer-c@chu-caen.fr+33(0)231065947
Backup ContactOlivier Join-Lambert, MD, PhD
olivier.join-lambert@unicaen.fr+33(0)231064895

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026