Infections With Enterobacteria Producing Carbapenemases at the University Hospitals of Strasbourg (CARBA)

August 6, 2021 updated by: University Hospital, Strasbourg, France

Infections With Enterobacteria Producing Carbapenemases at the University Hospitals of Strasbourg - Descriptive Epidemiology and Risk Factors for Infection in the Event of Colonization

Infections with enterobacteria producing carbapenemases at the University Hospitals of Strasbourg - descriptive epidemiology and risk factors for infection in the event of colonization

There is a worrying situation of an increase in the number of patients colonized with carbapenemase-producing Enterobacteriaceae (CPE) at HUS.

7 to 15% of patients colonized with EPC would develop an infection with EPC. The cohorts published mainly concern patients hospitalized in intensive care. The associated mortality reported in the literature is high (> 25%) and greater than that associated with infection with the same bacterium sensitive to carbapenems.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

274

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
      • Strasbourg, France, 67091
        • Recruiting
        • Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
        • Sub-Investigator:
          • Lucile HAUMESSER, Statistician
        • Contact:
        • Principal Investigator:
          • Yves HANSMANN, MD, PhD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Major subject with clinical sample or rectal screening smear finding an enterobacterium producing a carbapenemase

Description

Inclusion criteria:

  • Major subject (≥18 years old)
  • Subject hospitalized at HUS between 01/01/2011 and 07/31/2021
  • Clinical sample or rectal screening smear finding an enterobacterium producing a carbapenemase (EPC)
  • Subject not having expressed their opposition to participating in the study

Exclusion criteria:

  • Subject having expressed opposition to participating in the study
  • Subject under guardianship or guardianship
  • Subject under safeguard of justice

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
Time Frame
Retrospective study of Enterobacteriaceae infections producing carbapenemases
Time Frame: Files analysed retrospectively from January 01, 2011 to July 31, 2021 will be examined]
Files analysed retrospectively from January 01, 2011 to July 31, 2021 will be examined]

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Yves HANSMANN, MD, PhD, Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg

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)

August 6, 2021

Primary Completion (Anticipated)

January 6, 2022

Study Completion (Anticipated)

January 6, 2022

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8297 (CTEP)

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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