ClinicalTrials.Veeva

Menu

Intensive Care Unit Acquired Infections in Patients Colonized With Extended Spectrum Enterobacteriaceae (BMREA)

R

Regional University Hospital Center (CHRU)

Status

Unknown

Conditions

Ventilator Associated Pneumonia
Enterobacteriaceae Infections
Bacteremia
Abdominal Infection

Treatments

Other: observational

Study type

Observational

Funder types

Other

Identifiers

NCT04903886
BMREA ( 29BRC20.0019)

Details and patient eligibility

About

Worldwide emergence of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in ICU, with at least 10% of incidence at the admission in Europe. A systematic rectal swab is used in 70% of French ICU to detect intestinal ESBL-E carriage The relationship between intestinal carriage and ICU-acquired infection is not perfectly known. The investigators conducted a five years study monocentric retrospective observational cohort in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate which type of infections and which bacteria are involved.

The investigators also collect data about antibiotherapy used to treat these infections.

Full description

Intestinal carriage of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in general population, morover in intensive care units. Systematic rectal swab for screening is done in 70% of French ICU in routine. Some studies had show a good negative predictive value of this test for ICU-acquired infection (for example ventilator-associated pneumoniae), but a poor predictive positive value. The precise relationship between intestinal carriage and ICU-acquired infection is not perfectly known.

Probabilist antibiotherapy with carbapenem for ESBL-E suspected infection are currently recommanded by national and european Guidelines, particulary in case of shock or immunodepression.

A ESBL-E systematic screening-guided strategy for probabilist antibiotherapy could be interesting, and could lead to a carbapenem or a carbapenem-sparing focused antibiotherapy.

The investigators conducted a monocentric retrospective observational cohort study in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate the number of ESBL-E related infections, the site of these infections and which species of bacteriae are involved. They also investigate which was the antibiotherapy administered, and investigate what factors lead clinicians to treat the infection with carbapenem antibiotherapy.

Enrollment

350 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • admitted in Brest ICU (medical or surgical)
  • positive rectal swab for ESBL-Enterobacteriae screening at the admission or during the ICU stay
  • written consent

Exclusion criteria

  • refusing to participate

Trial design

350 participants in 1 patient group

All patient colonized with ESBL-E in Brest Intensive Care unit
Description:
All patient colonized with ESBL-E in Brest Intensive Care unit, in a 5 years period (2015-2019)
Treatment:
Other: observational

Trial contacts and locations

1

Loading...

Central trial contact

Philippe penven; Pierre Bailly

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems