Organ Failure, Multiple Clinical Trial
— ECLA'IROfficial title:
Impact of Fourier Transform Infrared Spectroscopy (FTIRS) on the Diffusion of ESBL Producing Enterobacterales in Intensive Care Units (ICU)
This study will assess the impact of FTIRS typing on the spread of ESBL-E in intensive care units
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
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
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 |
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