ECLA'IR: Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

Sponsor

University Hospital, Caen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05872152

Collaborator

(none)

900

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will assess the impact of FTIRS typing on the spread of ESBL-E in intensive care units

Condition or Disease	Intervention/Treatment	Phase
Organ Failure, Multiple	Diagnostic Test: FTIR results	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Stepped-wedgeStepped-wedge

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)

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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.	Diagnostic Test: FTIR results Weekly transmission of FTIRS typing of ESBL-E to centers

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.

Diagnostic Test: FTIR results

Weekly transmission of FTIRS typing of ESBL-E to centers

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

Sensitivity of FTIRS to diagnose cross transmissions compared to WGS [Month 24]
Sensitivity
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
Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS [Month 24]
Negative predictive value

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients hospitalized in ICU
ESBL-E carrier

Exclusion Criteria:

none

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Caen

Investigators

Principal Investigator: Camille Jeanne-Leroyer, PharmD, Caen Normandie Hospital
Study Director: Olivier Join-Lambert, MD, PhD, Caen Normandie University and Hospital