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)

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.

Study Overview

• Status: Unknown
• Conditions: Bacteremia; Enterobacteriaceae Infections; Ventilator Associated Pneumonia; Abdominal Infection
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of ESBL-E related infection in ICU-aquired infection	proportion of ESBL-E related infection in ICU-aquired infection	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
use of carbapenem antibiotherapy	use of carbapenem antibiotherapy	28 days
length of ICU-stay	length of ICU-stay	28 days
length of hospital-stay	length of hospital-stay	28 days
mortality rate in ICU	death in ICU	28 days
mortality in hospital	death in hospital	28 days

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Cross Infection; Iatrogenic Disease; Sepsis; Healthcare-Associated Pneumonia; Infections; Communicable Diseases; Intraabdominal Infections; Bacteremia; Pneumonia, Ventilator-Associated; Enterobacteriaceae Infections
• Other Study ID Numbers: BMREA ( 29BRC20.0019)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending five years maximum following the last visit of the last patient
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No