Prevention of Carbapenemase-producing Enterobacteriaceae Epidemics: Evaluation of a Simplified Contact Screening Policy (CADECO) (CADECO)

February 17, 2025 updated by: University Hospital, Brest

Prevention of Carbapenemase-producing Enterobacteriaceae Epidemics: Evaluation of a Simplified Contact Screening Policy

In France, carbapenemase-producing Enterobacteriaceae (CPE) are a significant concern due to their emergence. Efforts to limit their spread focus on reducing antibiotic selection pressure and preventing patient-to-patient transmission. The recommendations issued by the High Council for Public Health in 2010, updated in 2013 and 2019, emphasize the importance of identifying high-risk patients (those who have been hospitalized abroad in the past year) and implementing contact precautions, including single-room isolation and the use of protective clothing. Additional measures include assigning dedicated staff to CPE carriers when possible and conducting systematic weekly screening of all individuals exposed to the same medical or paramedical team, known as contact patient monitoring.

Despite their importance, these recommendations are challenging to implement. Firstly, they require significant resources due to the human and material constraints faced by healthcare systems. Secondly, a large number of contact patients are lost to follow-up and are not screened. The increasing prevalence of CPE carriers has further exacerbated these difficulties.

Epidemic outbreaks, defined by at least one secondary case of CPE carriage among contact patients, require additional control measures. French recommendations for managing an epidemic situation include halting patient transfers between departments, stopping new admissions, and organizing different sectors (CPE carriers, contact patients, and new patients) with dedicated staff for each sector until the outbreak is controlled (with three weeks without a new positive test among contact patients). These measures are even more costly and require time for discussions with hospital management, service reorganization, and hiring additional staff. The difficulties in implementing these measures can have negative effects, such as reduced quality of care and increased staff fatigue.

To address these challenges, some hospitals have adapted their strategies by replacing dedicated teams with a "forward movement" approach and conducting selective screening for only a subset of patients exposed to carriers, based on assessments by infection prevention and control (IPC) specialists. The simplified CPE management protocol was developed in late 2017 at our center. Before that date, French national recommendations for managing carriers and identifying outbreaks were followed. All contacts of a CPE carrier were screened weekly. In 2017, a CPE cohorting unit was implemented at the hospital level for a short period of approximately six months before being discontinued due to difficulties in maintaining continuity of care. In 2018, the selection of a subset of contact patients for screening during each CPE carrier's stay was gradually introduced, without a corresponding change in the definition of an epidemic.

The screening sample is determined by the IPC team based on the duration of contact with the CPE carrier, risk assessment, and geographical proximity. In case of an outbreak, screening is then expanded, and additional measures are implemented as previously described.

This is a retrospective cohort study including adult patients carrying carbapenemase-producing Enterobacteriaceae and comparing stays that resulted in outbreaks to those without outbreaks at Brest University Hospital in the medicine, surgery, or obstetrics departments.

Study Overview

Status

Active, not recruiting

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

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

Study Locations

      • Brest, France, 29609
        • CHU Brest

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

Patient carrying CPE according to HCSP definitions (2010), hospitalized for more than 24 hours at Brest University Hospital in a medicine, surgery, or obstetrics department between 2012 and 2023

Description

Inclusion Criteria:

  • Adult patient
  • Patient carrying CPE according to HCSP definitions (2010)
  • Hospitalized for more than 24 hours at Brest University Hospital in a medicine, surgery, or obstetrics department between 2012 and 2023
  • Patient affiliated with a social security system

Exclusion Criteria:

  • Patients under legal protection (guardianship, curatorship)
  • Deceased patients
  • Refusal 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
Detection of a CPE outbreak
Time Frame: untill 2022
is defined as the identification of CPE with the same resistance enzyme in at least one contact patient of a known carrier.
untill 2022

Collaborators and Investigators

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

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)

February 1, 2025

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 29BRC25.0003 - CADECO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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