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

Epidemiology of ICU-acquired Infections in Patients With Fecal Carriage of Extended Spectrum Betalactamase Enterobacteriaceae (ESBL-E)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04903886
Acronym
BMREA
Enrollment
350
Registered
2021-05-27
Start date
2021-06-01
Completion date
2021-12-01
Last updated
2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Infection, Bacteremia, Enterobacteriaceae Infections, Ventilator Associated Pneumonia

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.

Interventions

OTHERobservational

observational

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
proportion of ESBL-E related infection in ICU-aquired infection28 daysproportion of ESBL-E related infection in ICU-aquired infection

Secondary

MeasureTime frameDescription
use of carbapenem antibiotherapy28 daysuse of carbapenem antibiotherapy
length of ICU-stay28 dayslength of ICU-stay
length of hospital-stay28 dayslength of hospital-stay
mortality rate in ICU28 daysdeath in ICU
mortality in hospital28 daysdeath in hospital

Countries

France

Contacts

Primary ContactPierre Bailly
pierre.bailly@chu-brest.fr0298347181
Backup ContactPhilippe penven
philippe.penven@chu-brest.fr0298347181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026