Infections With Enterobacteria Producing Carbapenemases at the University Hospitals of Strasbourg

NCT ID: NCT04995965

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

274 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-06

Study Completion Date

2022-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nfections, Enterobacterial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yves HANSMANN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yves HANSMANN, MD, PhD

Role: CONTACT

33 3 69 55 09 78

Saïd CHAYER, PhD, HDR

Role: CONTACT

33 3 88 11 66 90

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yves HANSMANN, MD, PhD

Role: primary

33 3 69 55 09 78

Saïd CHAYER, PhD, HDR

Role: backup

33 3 88 11 66 90

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

8297

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.