Clinical trial NCT04903886: Intensive Care Unit Acquired Infections in Patients Colonized With Extended Spectrum Enterobacteriaceae
Official title: Epidemiology of ICU-acquired Infections in Patients With Fecal Carriage of Extended Spectrum Betalactamase Enterobacteriaceae (ESBL-E)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia
Bacteremia
Abdominal Infection
Enterobacteriaceae Infections
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of ESBL-E related infection in ICU-aquired infection
timeFrame: 28 days
Secondary outcomes:
measure: use of carbapenem antibiotherapy
timeFrame: 28 days
measure: length of ICU-stay
timeFrame: 28 days
measure: length of hospital-stay
timeFrame: 28 days
measure: mortality rate in ICU
timeFrame: 28 days
measure: mortality in hospital
timeFrame: 28 days
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: