Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients (DIACOBHR)

April 13, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

The propias, and more recently the update of the recommendations relating to the control of the spread of bacteria highly resistant to emerging antibiotics issued by the High Council of Public Health (December 2019), recommend the implementation of measures to maintain the rate of Carbapenemase-producing Enterobacteriaceae (EPC) such as Klebsiella pneumoniae (K. pneumoniae) isolated from bacteremia in healthcare establishments in France at less than 1%, and that of Vancomycin Resistant Enterococcus (VRE) belonging to Enterococci Resistant to Glycopeptides (ERG) such as Enterococcus faecium isolated from bacteremia in health establishments in France at less than 1% also. At the same time, the prevalence of colonized patients is increasing. One of the recommended measures concerns the fight against cross transmission.

Due to the high technicality of the treatments, the risks of cross-transmission are very high and present at each stage of the dialysis procedure. Screening and isolation of patients colonized with emerging Highly Resistant Bacteria (BHRe) is essential to avoid their spread and the risk of infection with these germs.

Screening is done using rectal swabs. If the patient is found to be a carrier of BHRe, he should be isolated. Isolation is made more difficult in the hemodialysis room due to their architectural configuration, the organization of care and the chronicity of the patients. Patients have a monthly sample.

The isolation is allowed after obtaining six consecutive negative rectal swabs, the number of which has been arbitrarily defined. Indeed, the negativation of the samples does not confirm the disappearance of the carriage (that is to say the presence of BHRe), hence the need to repeat them. Persistence of colonization at a rate below the detection limit is possible. With for corollaries:

  • Isolation which could be lifted more quickly in the event of real disappearance of the strain since the investigators know that a prolonged period of isolation can lead to a loss of opportunity for the patient and the investigators know its impact for the patient, on the operation of the service and its cost, with in particular the increase in withdrawals.
  • Isolation lifted too early in the event of persistent carriage with risk of secondary transmission.

The interest of this study is to determine the clearance of the carriage of BHRe, i.e. their disappearance, in the chronic dialysis patient and to define, secondly, the factors associated with the prolonged carriage corresponding to the presence of bacteria for more than 3 months. , and elements of answer concerning the early disappearance of the EPC in the event of co-colonization by ERG and EPC. The follow-up of this carriage for 1 year will make it possible to evaluate the relapse corresponding to the reappearance of the bacteria previously identified, the recolonization corresponding to the acquisition of a new BHR, or the reinfection corresponding to an infection with a new highly resistant bacterium.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

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
    • Groupe Hospitalier Paris Saint-Joseph
      • Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75014
      • Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75014
        • Recruiting
        • AURA Paris Plaisance
        • Contact:
        • Principal Investigator:
          • Cecile BOURGAIN, MD
      • Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75014
        • Recruiting
        • AURA Paris Site de Saint Ouen
      • Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint-Joseph
        • Contact:
        • Principal Investigator:
          • Benoit PILMIS, MD
      • Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75018

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

No

Description

Inclusion Criteria:

  • Adult patient (≥ 18 years old)
  • Patient with stage V chronic renal failure, treated by chronic dialysis (hemodialysis or peritoneal dialysis) and monitored at AURA Paris (AURA Paris Plaisance Dialyse and hospitalization, AURA Nord, AURA Corentin Celton, AURA Bichat)
  • Patient affiliated to a health insurance plan
  • French-speaking patient
  • Patient who has given free, informed and written consent

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under legal protection
  • Pregnant or breastfeeding woman

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).
Other: Control
During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).
Experimental: BHR Case

During follow-up visits, compared to the usual management of patients with BHRe (monthly sampling for 6 consecutive months), additional samples are taken as described below:

- stool samples taken at different times:

  • every 7 days during the first month (M1)
  • every 14 days for the following months until the end of the patient's participation (M2 to M12).
Other: BHR Case

During follow-up visits, compared to the usual management of patients with BHRe (monthly sampling for 6 consecutive months), additional samples are taken as described below:

- stool samples taken at different times:

  • every 7 days during the first month (M1)
  • every 14 days for the following months until the end of the patient's participation (M2 to M12).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with disappearance of Carriage of bacteria
Time Frame: Year 1
This outcome corresponds to the disappearance of the carriage of the emerging highly resistant bacteria over the follow-up period of one year.
Year 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of BHR carriage
Time Frame: Year 1
This outcome corresponds to the proportion of patients with emerging highly resistant bacteria.
Year 1
Comparison of Prevalence of BHR carriage between the 2 groups
Time Frame: Year 1
This outcome corresponds to the comparison of carriage of emerging highly resistant bacteria between case patients and control patients.
Year 1

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Cecile BOURGAIN, MD, AURA Paris Plaisance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 15, 2021

Primary Completion (Anticipated)

January 14, 2024

Study Completion (Anticipated)

March 14, 2025

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIACOBHR

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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