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NCT Number: NCT05872152

Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

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

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU CHEN

Caen, France

Location status: Recruiting

Location contact

JOIN LAMBERT

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients hospitalized in ICU
  • ESBL-E carrier

Exclusion criteria

  • none

Treatment and study plan

FTIR results

Diagnostic Test

Weekly transmission of FTIRS typing of ESBL-E to centers

Primary outcomes

  1. Baseline frequency of ESBL-E cross transmission as assessed by WGS

    Time frame: 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

  2. Post intervention frequency of ESBL-E cross transmission as assessed by WGS

    Time frame: Month 24

    Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers

Secondary outcomes

  1. Sensitivity of FTIRS to diagnose cross transmissions compared to WGS

    Time frame: Month 24

    Sensitivity

  2. Specificity of FTIRS to diagnose cross transmissions compared to WGS

    Time frame: Month 24

    Specificity

  3. Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS

    Time frame: Month 24

    Positive predictive value

  4. Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS

    Time frame: Month 24

    Negative predictive value

Study contacts

Contact information is provided by the study sponsor or research team.

Camille Jeanne-Leroyer

CONTACT

[email protected]

+33(0)231065947

Olivier Join-Lambert, MD, PhD

CONTACT

[email protected]

+33(0)231064895

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: ECLA'IR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 24, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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