Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

NCT ID: NCT05872152

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2026-09-01

Brief Summary

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

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.

Conditions

Organ Failure, Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

FTIR results

Intervention Type: DIAGNOSTIC_TEST

Weekly transmission of FTIRS typing of ESBL-E to centers

Interventions

FTIR results

Weekly transmission of FTIRS typing of ESBL-E to centers

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Adult patients hospitalized in ICU
• ESBL-E carrier

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camille Jeanne-Leroyer, PharmD

Role: PRINCIPAL_INVESTIGATOR

Caen Normandie Hospital

Olivier Join-Lambert, MD, PhD

Role: STUDY_DIRECTOR

Caen Normandie University and Hospital

Locations

CHU CHEN

Caen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Camille Jeanne-Leroyer

Role: CONTACT

jeanneleroyer-c@chu-caen.fr

+33(0)231065947

Olivier Join-Lambert, MD, PhD

Role: CONTACT

olivier.join-lambert@unicaen.fr

+33(0)231064895

Facility Contacts

JOIN LAMBERT

Role: primary

jointlambert-o@chu-caen.fr

References

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.

Reference Type: BACKGROUND

PMID: 30483997 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33921159 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32643025 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30135233 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32161093 (View on PubMed)

Other Identifiers

220145

Identifier Type: -

Identifier Source: org_study_id