Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Unit (EB3REA)

Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Impact on the Mortality and Morbidity

There is a lack of data whether colonization and infection with Enterobacteriaceae of the third group (EB3) affect the outcomes for ICU patients. This study evaluated the effects of EB3 colonization and infection on ICU mortality, ICU length of stay (LOS) and broad-spectrum antibiotic exposure. We focused on the sub type Enterobacter regarding its a priori higher risk of resistance.

Study Overview

• Status: Completed
• Conditions: Enterobacteriaceae Infections; Critically Ill; Antibiotic Resistant Infection

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Vandoeuvre Les Nancy, Lorraine, France, 54500
      • Emmanuel NOVY

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 adults (≥ 18 years-old) patients admitted in the participating ICUs with LOS ≥ 24 hours during the study period were enrolled if they had presented a colonization and/or an infection caused by an EB3 (Enterobacter cloacae, Enterobacter aerogenes, Morganella morganii, Serratia marcescens, Hafnia alvei et Citrobacter freundii), from 1st January 2016 to 31th December 2016.

Participating ICUs of the university hospital of Nancy:

• two Medical ICU
• 3 surgical ICU

Description

Inclusion Criteria:

• adults critically ill patients admitted to the the participating ICUs during the study period
• with colonization and/or infection with a third group enterobacteriacea
• and with a lenght of stay > 24h

Exclusion Criteria:

• minors patients
• lenght of stay < 24h

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
critically ill patients; critically ill patients admitted in one of the 5 ICUs of the university hospital of Nancy during the year 2016 with documented third group enterobacteriaceae infection and/or colonization with third group enterobacteriaceae

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all cause mortality	Evaluation of the impact of colonization and/or infection with third group enterobacteriaceae on mortality during hospitalization and up to 180 day	Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resistance strains of sub type enterobacter	Evaluation of number of resistant strains among Enterobacter subtype in comparison with other third group enterobacteriaceae	DAY 90

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ACTUAL): January 10, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (ACTUAL): August 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: infection; colonization; resistance; Third group Enterobacteriaceae; AMPc cephalosporinase
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Critical Illness; Enterobacteriaceae Infections
• Other Study ID Numbers: PSS2018/EB3REA-NOVY/YB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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