Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

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

Detailed Description
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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.

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

Conditions
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Organ Failure, Multiple

Intervention / Treatment
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* Diagnostic Test: FTIR results


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients hospitalized in ICU ESBL-E carrier Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped-wedge
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>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<br>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<br>* Weekly transmission of FTIRS typing of ESBL-E to centers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of FTIRS to diagnose cross transmissions compared to WGS | Sensitivity | Month 24 | 
| Specificity of FTIRS to diagnose cross transmissions compared to WGS | Specificity | Month 24 | 
| Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS | Positive predictive value | Month 24 | 
| Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS | Negative predictive value | Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multidrug resistant bacteria, outbreak, prevention and infection control, bacterial typing, Fourier transform infrared spectroscopy