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

NCT ID: NCT04903886

Last Updated: 2021-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-01

Brief Summary

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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

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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.

Conditions

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Ventilator Associated Pneumonia Bacteremia Abdominal Infection Enterobacteriaceae Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All patient colonized with ESBL-E in Brest Intensive Care unit

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

observational

Intervention Type OTHER

observational

Interventions

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observational

observational

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest

Brest, , France

Site Status

Countries

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France

Central Contacts

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Pierre Bailly

Role: CONTACT

0298347181

Philippe penven

Role: CONTACT

0298347181

Facility Contacts

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Pierre Bailly

Role: primary

0298347181

Other Identifiers

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BMREA ( 29BRC20.0019)

Identifier Type: -

Identifier Source: org_study_id

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