NCT07345923
Recruiting
Not Applicable
Predictive Value of a Rectal Swab With Detection of Enterobacteria (ESBL-E), Carbapenemases, and High-level Cephalosporinase (HLC) on the Risk of Infections With C3G-resistant Enterobacteria in Intensive Care
University Hospital, Strasbourg, France1 site in 1 country1,000 target enrollmentStarted: October 6, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Strasbourg, France
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Negative predictive value of a negative rectal swab for the risk of infection with ESBL-producing Enterobacteriaceae
Overview
Brief Summary
The objective of the research is to evaluate the value of testing for ESBL carriage by rectal swab to predict the risk of ESBL-producing Enterobacteriaceae infections in intensive care.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (≥ 18 years old)
- •Who have been in medical or surgical intensive care at Strasbourg University Hospitals (between January 1, 2024, and January 1, 2025)
- •Who have undergone rectal screening for carriage of ESBL/HLC/carbapenemase-producing Enterobacteriaceae
Exclusion Criteria
- •Refusal to participate in the study
Outcomes
Primary Outcomes
Negative predictive value of a negative rectal swab for the risk of infection with ESBL-producing Enterobacteriaceae
Time Frame: Up to 12 months
The negative predictive value (NPV) answers the following question: When the test is negative, what is the probability that the person will not develop an infection with these resistant bacteria? For example: * Out of 100 people with a negative smear test, * if 95 never develop an infection, then the negative predictive value is 95%.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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