Prognostic Factors and Therapeutic Management of ESBL Enterobacteriaceae in the ICU (BLSE-REA)

April 26, 2023 updated by: Tourcoing Hospital
Multicenter retrospective study conducted in the intensive care units of Tourcoing, Roubaix, and Lille hospitals. Patients hospitalized in the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU will be selected from microbiology laboratory data. Patient demographics and clinical data will be collected from the medical record. Microbiological results will be collected from the laboratory data.

Study Overview

Status

Recruiting

Conditions

Detailed Description

INCLUSION CRITERIA - Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.

PRIMARY ENDPOINT

- The primary endpoint is 30-day mortality.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Tourcoing, France, 59208
        • Recruiting
        • Centre Hospitalier DRON
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the ICU with EBLSE bacteremia

Description

Inclusion Criteria:

  • Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.

Exclusion Criteria:

  • Patient who is a minor, protected adult, or who refuses to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is all-cause 30-day mortality.
Time Frame: 30-day mortality
all-cause mortality.
30-day mortality

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy of initial antibiotic therapy to french recommendations
Time Frame: adequate within 30 days
Antibiotic prescriptions will be considered adequate if all of the following criteria meet the recommendations: molecule, dose, according to the recommendations provided by the French Society of Infectious Diseases. The recommendations for prescribing antibiotics are similar to those proposed by international guidelines.
adequate within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tourcoing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NRIPH_2023_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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