Recruiting

NCT Number: NCT07345923

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

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.

Recruiting

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Key information

Conditions

Infections, Enterobacteriaceae Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Alice UNTERFINGER, MD

PRINCIPAL_INVESTIGATOR

Baptiste Hoellinger, MD

CONTACT

[email protected]

33 3 69 55 05 45

Baptiste Hoellinger, MD

PRINCIPAL_INVESTIGATOR

François Danion, MD

SUB_INVESTIGATOR

François SEVERAC, Statistician

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%.

Study contacts

Contact information is provided by the study sponsor or research team.

baptiste Hoellinger, MD

CONTACT

[email protected]

33 3 69 55 05 45

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: SCREEN ICU

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jan 16, 2026
Registry last updated: Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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Recruiting