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RecruitingNCT07345923SCREEN ICUUpdated Jan 16, 2026

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

An observational study in Infections, Enterobacteriaceae, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Infections, Enterobacteriaceae

Keywords

  • Infections, Enterobacteriaceae
  • Enterobacterial Infections
  • High-level cephalosporinase
  • Carbapenemases
  • C3G-resistant enterobacteria
03

In context

Enterobacteriaceae Infections

59 studies on the registry are indexed under Enterobacteriaceae Infections; 14 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 300 across 30 observational studies indexed under Enterobacteriaceae Infections.

Browse Enterobacteriaceae Infections studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Browse University Hospital, Strasbourg, France studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Refusal to participate in the study
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Negative predictive value of a negative rectal swab for the risk of infection with ESBL-producing Enterobacteriaceae

    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%.

    Time frame: Up to 12 months

07

Study locations

1 of 1 sites recruiting
  • Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
    Strasbourg, 67091, France
    Recruiting
    • Baptiste Hoellinger, MD · Contactbaptiste.hoellinger@chru-strasbourg.fr · 33 3 69 55 05 45
    • Baptiste Hoellinger, MD · Principal investigator
    • Alice UNTERFINGER, MD · Principal investigator
    • François Danion, MD · Sub investigator
    • François SEVERAC, Statistician · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07345923
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jan 16, 2026
Start date
Oct 6, 2025
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Jan 16, 2026

Study contacts

baptiste Hoellinger, MD
Contact
baptiste.hoellinger@chru-strasbourg.fr
33 3 69 55 05 45

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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