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Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs (ECLA'IR)

Primary Purpose

Organ Failure, Multiple

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FTIR results
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Organ Failure, Multiple focused on measuring multidrug resistant bacteria, outbreak, prevention and infection control, bacterial typing, Fourier transform infrared spectroscopy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard care

    Transmission of FTIR results

    Arm Description

    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)

    In second phase of the study, the result of FTIR typing of recovered ESBL-E isolates will be weekly transmitted to participating centers.

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    Sensitivity of FTIRS to diagnose cross transmissions compared to WGS
    Sensitivity
    Specificity of FTIRS to diagnose cross transmissions compared to WGS
    Specificity
    Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS
    Positive predictive value
    Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS
    Negative predictive value

    Full Information

    First Posted
    April 11, 2023
    Last Updated
    May 22, 2023
    Sponsor
    University Hospital, Caen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05872152
    Brief Title
    Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs
    Acronym
    ECLA'IR
    Official Title
    Impact of Fourier Transform Infrared Spectroscopy (FTIRS) on the Diffusion of ESBL Producing Enterobacterales in Intensive Care Units (ICU)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2025 (Anticipated)
    Study Completion Date
    September 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Caen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Organ Failure, Multiple
    Keywords
    multidrug resistant bacteria, outbreak, prevention and infection control, bacterial typing, Fourier transform infrared spectroscopy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    Stepped-wedge
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    900 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard care
    Arm Type
    No Intervention
    Arm Description
    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)
    Arm Title
    Transmission of FTIR results
    Arm Type
    Experimental
    Arm Description
    In second phase of the study, the result of FTIR typing of recovered ESBL-E isolates will be weekly transmitted to participating centers.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    FTIR results
    Intervention Description
    Weekly transmission of FTIRS typing of ESBL-E to centers
    Primary Outcome Measure Information:
    Title
    Baseline frequency of ESBL-E cross transmission as assessed by WGS
    Description
    Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers
    Time Frame
    Month 9 to Month 12 (depending on centers, stepped wedge design)
    Title
    Post intervention frequency of ESBL-E cross transmission as assessed by WGS
    Description
    Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers
    Time Frame
    Month 24
    Secondary Outcome Measure Information:
    Title
    Sensitivity of FTIRS to diagnose cross transmissions compared to WGS
    Description
    Sensitivity
    Time Frame
    Month 24
    Title
    Specificity of FTIRS to diagnose cross transmissions compared to WGS
    Description
    Specificity
    Time Frame
    Month 24
    Title
    Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS
    Description
    Positive predictive value
    Time Frame
    Month 24
    Title
    Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS
    Description
    Negative predictive value
    Time Frame
    Month 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients hospitalized in ICU ESBL-E carrier Exclusion Criteria: none
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Camille Jeanne-Leroyer
    Phone
    +33(0)231065947
    Email
    jeanneleroyer-c@chu-caen.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Olivier Join-Lambert, MD, PhD
    Phone
    +33(0)231064895
    Email
    olivier.join-lambert@unicaen.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Camille Jeanne-Leroyer, PharmD
    Organizational Affiliation
    Caen Normandie Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Olivier Join-Lambert, MD, PhD
    Organizational Affiliation
    Caen Normandie University and Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30483997
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    33921159
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    32643025
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    30135233
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    32161093
    Citation
    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.
    Results Reference
    result

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    Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

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