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 (SCREEN ICU)

January 7, 2026 updated by: University Hospital, Strasbourg, France

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
        • Sub-Investigator:
          • François Danion, MD
        • Sub-Investigator:
          • François SEVERAC, Statistician
        • Contact:
        • Principal Investigator:
          • Baptiste Hoellinger, MD
        • Principal Investigator:
          • Alice UNTERFINGER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients who have undergone rectal screening for carriage of ESBL/HLC/carbapenemase-producing Enterobacteriaceae

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9826

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infections, Enterobacteriaceae

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe