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

Bacteremia Clinical Trial

— BMREA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04903886
• Other study ID #: BMREA ( 29BRC20.0019)
• Status: Not yet recruiting
• Start date: June 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2021
• Source: University Hospital, Brest
• Contact: Pierre Bailly
• Phone: 0298347181
• Email: pierre.bailly[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Infection
• Bacteremia
• Communicable Diseases
• Enterobacteriaceae Infections
• Infection
• Intraabdominal Infections
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Other:
• observational
observational

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of ESBL-E related infection in ICU-aquired infection	proportion of ESBL-E related infection in ICU-aquired infection	28 days
Secondary	use of carbapenem antibiotherapy	use of carbapenem antibiotherapy	28 days
Secondary	length of ICU-stay	length of ICU-stay	28 days
Secondary	length of hospital-stay	length of hospital-stay	28 days
Secondary	mortality rate in ICU	death in ICU	28 days
Secondary	mortality in hospital	death in hospital	28 days