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

• Conditions: Bacteremia; Ventilator Associated Pneumonia; Abdominal Infection; Enterobacteriaceae Infections
• Interventions: Other: observational

• Registration Number: NCT04903886
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Study First Posted: 2021-05-27
• Last Update Posted: 2021-05-27
• Study Start: 2021-06-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
proportion of ESBL-E related infection in ICU-aquired infection	28 days	proportion of ESBL-E related infection in ICU-aquired infection

Secondary Outcome Measures

Name	Time	Method
mortality rate in ICU	28 days	death in ICU
length of ICU-stay	28 days	length of ICU-stay
length of hospital-stay	28 days	length of hospital-stay
mortality in hospital	28 days	death in hospital
use of carbapenem antibiotherapy	28 days	use of carbapenem antibiotherapy

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France