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

Sponsor
University Hospital, Brest (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04903886
Collaborator
(none)
350
1
6
58.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: observational

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 Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Epidemiology of ICU-acquired Infections in Patients With Fecal Carriage of Extended Spectrum Betalactamase Enterobacteriaceae (ESBL-E)
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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)

Other: observational
observational

Outcome Measures

Primary Outcome Measures

  1. 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

  1. use of carbapenem antibiotherapy [28 days]

    use of carbapenem antibiotherapy

  2. length of ICU-stay [28 days]

    length of ICU-stay

  3. length of hospital-stay [28 days]

    length of hospital-stay

  4. mortality rate in ICU [28 days]

    death in ICU

  5. mortality in hospital [28 days]

    death in hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU de Brest Brest France 29609

Sponsors and Collaborators

  • University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT04903886
Other Study ID Numbers:
  • BMREA ( 29BRC20.0019)
First Posted:
May 27, 2021
Last Update Posted:
May 27, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2021