Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs
ConditionOrgan Failure, Multiple
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Hospital, Caen
About this trial
This study will assess the impact of FTIRS typing on the spread of ESBL-E in intensive care units
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients hospitalized in ICU
ESBL-E carrier
Disqualifiers
none
Trial design
Design model
Sequential
Treatments tested in this trial
FTIR results
Diagnostic testWeekly transmission of FTIRS typing of ESBL-E to centers
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: Standard careNo intervention 0 interventions
Group B: Transmission of FTIR resultsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Month 9 to Month 12 (depending on centers, stepped wedge design)2
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
Time frame
Month 24Secondary outcomes
1
Sensitivity of FTIRS to diagnose cross transmissions compared to WGS
Sensitivity
Time frame
Month 242
Specificity of FTIRS to diagnose cross transmissions compared to WGS
Specificity
Time frame
Month 243
Positive predictive value of FTIRS to diagnose cross transmissions compared to WGS
Positive predictive value
Time frame
Month 244
Negative predictive value of FTIRS to diagnose cross transmissions compared to WGS
Negative predictive value
Time frame
Month 24Sponsors and contacts
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Source ClinicalTrials.gov