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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07345923

Acronym

SCREEN ICU

Enrollment

1000

Registered

2026-01-16

Start date

2025-10-06

Completion date

2027-04-01

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Enterobacteriaceae

Keywords

Infections, Enterobacteriaceae, Enterobacterial Infections, High-level cephalosporinase, Carbapenemases, C3G-resistant enterobacteria

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Negative predictive value of a negative rectal swab for the risk of infection with ESBL-producing Enterobacteriaceae	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%.

Countries

France

Contacts

CONTACTbaptiste Hoellinger, MD

baptiste.hoellinger@chru-strasbourg.fr33 3 69 55 05 45

Outcome results