Intensive Care Unit Acquired Infections in Patients Colonized With Extended Spectrum Enterobacteriaceae
BMREA
Epidemiology of ICU-acquired Infections in Patients With Fecal Carriage of Extended Spectrum Betalactamase Enterobacteriaceae (ESBL-E)
1 other identifier
observational
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMay 27, 2021
February 1, 2021
3 months
April 28, 2021
May 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
proportion of ESBL-E related infection in ICU-aquired infection
proportion of ESBL-E related infection in ICU-aquired infection
28 days
Secondary Outcomes (5)
use of carbapenem antibiotherapy
28 days
length of ICU-stay
28 days
length of hospital-stay
28 days
mortality rate in ICU
28 days
mortality in hospital
28 days
Study Arms (1)
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)
Interventions
Eligibility Criteria
All patient admitted in the ICU during a 5 years period (2015-2019) with a positive rectal swab for ESBL-Enterobacteriae screening at the admission or during the ICU stay
You may qualify if:
- admitted in Brest ICU (medical or surgical)
- positive rectal swab for ESBL-Enterobacteriae screening at the admission or during the ICU stay
- written consent
You may not qualify if:
- refusing to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de Brest
Brest, 29609, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 27, 2021
Study Start
June 1, 2021
Primary Completion
September 1, 2021
Study Completion
December 1, 2021
Last Updated
May 27, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available after the publication of result and ending five years maximum following the last visit of the last patient
- Access Criteria
- Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement
All collected data that underlie results in a publication