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NCT04528043 Clinical Trial

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

Critically Ill Clinical Trial

— EB3REA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04528043
Other study ID # PSS2018/EB3REA-NOVY/YB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date December 31, 2019

Study information
Verified date February 2020
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 179
Est. completion date December 31, 2019
Est. primary completion date January 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Emmanuel NOVY Vandoeuvre Les Nancy Lorraine

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

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