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This study will assess the impact of FTIRS typing on the spread of ESBL-E in intensive care units
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTIR results | Diagnostic Test | Weekly transmission of FTIRS typing of ESBL-E to centers |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of FTIRS to diagnose cross transmissions compared to WGS | Sensitivity | Month 24 |
| Specificity of FTIRS to diagnose cross transmissions compared to WGS | Specificity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Camille Jeanne-Leroyer, PharmD | Caen Normandie Hospital | Principal Investigator |
| Olivier Join-Lambert, MD, PhD | Caen Normandie University and Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU CHEN | Recruiting | Caen | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30483997 | Result | 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. | |
| 33921159 | Result | 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. |
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| ID | Term |
|---|---|
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Stepped-wedge
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| Month 24 |
| Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS | Positive predictive value | Month 24 |
| Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS | Negative predictive value | Month 24 |
| 32643025 | Result | 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. |
| 30135233 | Result | 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. |
| 32161093 | Result | 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. |