Clinical trial NCT05872152: Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs
Official title: Impact of Fourier Transform Infrared Spectroscopy (FTIRS) on the Diffusion of ESBL Producing Enterobacterales in Intensive Care Units (ICU)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Organ Failure, Multiple
Keywords: multidrug resistant bacteria
outbreak
prevention and infection control
bacterial typing
Fourier transform infrared spectroscopy
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Adult patients hospitalized in ICU
* ESBL-E carrier

Exclusion Criteria:

* none

Primary outcomes:
measure: Baseline frequency of ESBL-E cross transmission as assessed by WGS
timeFrame: Month 9 to Month 12 (depending on centers, stepped wedge design)
measure: Post intervention frequency of ESBL-E cross transmission as assessed by WGS
timeFrame: Month 24
Secondary outcomes:
measure: Sensitivity of FTIRS to diagnose cross transmissions compared to WGS
timeFrame: Month 24
measure: Specificity of FTIRS to diagnose cross transmissions compared to WGS
timeFrame: Month 24
measure: Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS
timeFrame: Month 24
measure: Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS
timeFrame: Month 24
Other outcomes:
Locations:
Study officials:
affiliation: Caen Normandie Hospital
name: Camille Jeanne-Leroyer, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Caen Normandie University and Hospital
name: Olivier Join-Lambert, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.