Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID05872152

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

Led by University Hospital, Caen · Updated on 2025-07-24

900

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Multidrug resistant enterobacterales (MDR-E) pose a significant risk to patients in intensive care units (ICUs). This research aims to evaluate the use of Fourier Transform Infrared Spectroscopy (FTIRS) typing to detect and prevent the spread of extended spectrum beta-lactamase producing enterobacteriaceae (ESBL-E) in ICUs. FTIRS offers a faster and simpler alternative to whole genome sequencing (WGS), which is costly and less accessible. The study has two main phases. Initially, the frequency of ESBL-E cross transmission will be assessed using WGS on the first ESBL-E isolate from carrier patients in each center. In the second phase, weekly FTIRS typing results of ESBL-E isolates will be shared with participating centers to assess its impact on preventing spread. Standard care practices to control MDR-E spread will continue throughout. Participants are adult ICU patients who carry ESBL-E. Researchers will monitor the rate of ESBL-E cross transmission before and after sharing FTIRS results, using WGS to confirm transmissions. Outcome measures include sensitivity, specificity, and predictive values of FTIRS compared to WGS. The study will follow participants up to 24 months, with regular bacterial sampling and data review to evaluate the effectiveness of FTIRS in real-world ICU settings.

CONDITIONS

Brief Title

Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients hospitalized in ICU
  • ESBL-E carrier
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 24 months

Participants who undergo routine ICU care are observed for the presence and spread of ESBL-producing Enterobacterales using standard bacterial culturing and whole genome sequencing techniques.

Weekly assessments

Surveillance with FTIRS Typing

Duration - Up to 24 months

Participants in the experimental group have FTIRS typing performed weekly on recovered ESBL-E isolates to rapidly identify cross-transmissions and support infection control measures.

Weekly assessments

Trial Site Locations

Total: 1 location

1

CHU CHEN

Caen, France

Actively Recruiting

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Research Team

C

Camille Jeanne-Leroyer

O

Olivier Join-Lambert, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Classification of Salmonella enterica of the (Para-)Typhoid Fever Group by Fourier-Transform Infrared (FTIR) Spectroscopy.

Miriam Cordovana, Norman Mauder, Markus Kostrzewa...

https://pubmed.ncbi.nlm.nih.gov/33921159

Fourier transform infrared (FT-IR) spectroscopy typing: a real-time analysis of an outbreak by carbapenem-resistant Klebsiella pneumoniae.

Liliana Silva, Carla Rodrigues, Agostinho Lira...

https://pubmed.ncbi.nlm.nih.gov/32643025

Typing and Species Identification of Clinical Klebsiella Isolates by Fourier Transform Infrared Spectroscopy and Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry.

Ariane G Dinkelacker, Sophia Vogt, Philipp Oberhettinger...

https://pubmed.ncbi.nlm.nih.gov/30135233

Fourier Transform Infrared Spectroscopy Is a New Option for Outbreak Investigation: a Retrospective Analysis of an Extended-Spectrum-Beta-Lactamase-Producing Klebsiella pneumoniae Outbreak in a Neonatal Intensive Care Unit.

Nadya Rakovitsky, Sammy Frenk, Hadas Kon...

https://pubmed.ncbi.nlm.nih.gov/32161093