CHU CHEN
Caen, France
Location status: Recruiting
NCT Number: NCT05872152
This study will assess the impact of FTIRS typing on the spread of ESBL-E in intensive care units
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Caen, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly transmission of FTIRS typing of ESBL-E to centers
Time frame: Month 9 to Month 12 (depending on centers, stepped wedge design)
Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers
Time frame: Month 24
Number of patients with hospital acquired ESBL-E / total number of ESBL-E carriers
Time frame: Month 24
Sensitivity
Time frame: Month 24
Specificity
Time frame: Month 24
Positive predictive value
Time frame: Month 24
Negative predictive value
Contact information is provided by the study sponsor or research team.
Camille Jeanne-Leroyer
CONTACT
Olivier Join-Lambert, MD, PhD
CONTACT
University Hospital, Caen
Other
Impact of Fourier Transform Infrared Spectroscopy (FTIRS) on the Diffusion of ESBL Producing Enterobacterales in Intensive Care Units (ICU)
Acronym: ECLA'IR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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