Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

NCT05872152 | Recruiting DMC

• 1 other identifier: 220145
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Organ Failure, Multiple

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Sensitivity of FTIRS to diagnose cross transmissions compared to WGS

  Month 24

• Specificity of FTIRS to diagnose cross transmissions compared to WGS

  Month 24

• Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS

  Month 24

• Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS

  Month 24

Study Arms (2)

Standard care

NO INTERVENTION

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)

Transmission of FTIR results

EXPERIMENTAL

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

Interventions

FTIR results DIAGNOSTIC_TEST

Weekly transmission of FTIRS typing of ESBL-E to centers

Transmission of FTIR results

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients hospitalized in ICU
• ESBL-E carrier

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU CHEN

Caen, France

RECRUITING

Related Publications (5)

• Novais A, Freitas AR, Rodrigues C, Peixe L. Fourier transform infrared spectroscopy: unlocking fundamentals and prospects for bacterial strain typing. Eur J Clin Microbiol Infect Dis. 2019 Mar;38(3):427-448. doi: 10.1007/s10096-018-3431-3. Epub 2018 Nov 27.

  PMID: 30483997 BACKGROUND

• Cordovana M, Mauder N, Kostrzewa M, Wille A, Rojak S, Hagen RM, Ambretti S, Pongolini S, Soliani L, Justesen US, Holt HM, Join-Lambert O, Hello SL, Auzou M, Veloo AC, May J, Frickmann H, Dekker D. Classification of Salmonella enterica of the (Para-)Typhoid Fever Group by Fourier-Transform Infrared (FTIR) Spectroscopy. Microorganisms. 2021 Apr 15;9(4):853. doi: 10.3390/microorganisms9040853.

  PMID: 33921159 BACKGROUND

• Silva L, Rodrigues C, Lira A, Leao M, Mota M, Lopes P, Novais A, Peixe L. Fourier transform infrared (FT-IR) spectroscopy typing: a real-time analysis of an outbreak by carbapenem-resistant Klebsiella pneumoniae. Eur J Clin Microbiol Infect Dis. 2020 Dec;39(12):2471-2475. doi: 10.1007/s10096-020-03956-y. Epub 2020 Jul 8.

  PMID: 32643025 BACKGROUND

• Dinkelacker AG, Vogt S, Oberhettinger P, Mauder N, Rau J, Kostrzewa M, Rossen JWA, Autenrieth IB, Peter S, Liese J. Typing and Species Identification of Clinical Klebsiella Isolates by Fourier Transform Infrared Spectroscopy and Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry. J Clin Microbiol. 2018 Oct 25;56(11):e00843-18. doi: 10.1128/JCM.00843-18. Print 2018 Nov.

  PMID: 30135233 BACKGROUND

• Rakovitsky N, Frenk S, Kon H, Schwartz D, Temkin E, Solter E, Paikin S, Cohen R, Schwaber MJ, Carmeli Y, Lellouche J. 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. J Clin Microbiol. 2020 Apr 23;58(5):e00098-20. doi: 10.1128/JCM.00098-20. Print 2020 Apr 23.

  PMID: 32161093 BACKGROUND

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Camille Jeanne-Leroyer, PharmD

  Caen Normandie Hospital

  PRINCIPAL INVESTIGATOR

• Olivier Join-Lambert, MD, PhD

  Caen Normandie University and Hospital

  STUDY DIRECTOR

Central Study Contacts

Camille Jeanne-Leroyer

CONTACT

+33(0)231065947; jeanneleroyer-c@chu-caen.fr

Olivier Join-Lambert, MD, PhD

CONTACT

+33(0)231064895; olivier.join-lambert@unicaen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 24, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)