Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

Organ Failure, Multiple Clinical Trial

— ECLA'IR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05872152
• Other study ID #: 220145
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2023
• Source: University Hospital, Caen
• Contact: Camille Jeanne-Leroyer
• Phone: +33(0)231065947
• Email: jeanneleroyer-c[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult patients hospitalized in ICU

• ESBL-E carrier

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Multiple Organ Failure
• Organ Failure, Multiple

Intervention

Diagnostic Test:
• FTIR results
Weekly transmission of FTIRS typing of ESBL-E to centers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

References & Publications (5)

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-)Typhoi — View 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 Deso — View 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 2 — View 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 — View 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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Sensitivity of FTIRS to diagnose cross transmissions compared to WGS	Sensitivity	Month 24
Secondary	Specificity of FTIRS to diagnose cross transmissions compared to WGS	Specificity	Month 24
Secondary	Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS	Positive predictive value	Month 24
Secondary	Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS	Negative predictive value	Month 24