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Completed

NCT Number: NCT04528043

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

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.

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Key information

Conditions

Critically Ill Antibiotic Resistant Infection Bacterial Infections Bacterial Infections and Mycoses Critical Illness Disease Attributes Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emmanuel NOVY

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. all cause mortality

    Time frame: Day 180

    Evaluation of the impact of colonization and/or infection with third group enterobacteriaceae on mortality during hospitalization and up to 180 day

Secondary outcomes

  1. Resistance strains of sub type enterobacter

    Time frame: DAY 90

    Evaluation of number of resistant strains among Enterobacter subtype in comparison with other third group enterobacteriaceae

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: EB3REA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 27, 2020
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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