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

NCT04528043 | Completed

• 1 other identifier: PSS2018/EB3REA-NOVY/YB
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critically Ill; Enterobacteriaceae Infections; Antibiotic Resistant Infection

Keywords

Third group Enterobacteriaceae; infection; colonization; resistance; AMPc cephalosporinase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Resistance strains of sub type enterobacter

  DAY 90

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• minors patients
• lenght of stay \< 24h

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Emmanuel NOVY

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

MeSH Terms

Conditions

Critical Illness; Enterobacteriaceae Infections; Infections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: April 1, 2017
• Primary Completion: January 10, 2019
• Study Completion: December 31, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)