Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients

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

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2025-03-14

Brief Summary

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

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Carbapenemase-Producing Organism and Vancomycin-Resistant Enterococcus Management

NCT05200546

Multidrug-resistant Bacteria Screening

COMPLETED

Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases

NCT02127450

Enterobacteria Non Susceptible to Carbapenem Carrier Enterobacteria Susceptible to Carbapenem Carrier

COMPLETED

Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae

NCT02420366

Urinary Tract Infection, Complicated Acute Pyelonephritis Hospital Acquired Bacterial Pneumonia +2 more

COMPLETED

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

NCT06839911

Carbapenemase-Producing Enterobacteriaceae

ACTIVE_NOT_RECRUITING

Can the Relative Fecal Abundance of BLSE and the Digestive Microbiota be Predictive of the Risk of Infection in a Carrier Patient?

NCT04699981

Enterobacteria Infections

UNKNOWN NA

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.

Chronic Kidney Diseases Dialysis

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).

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).

Group Type EXPERIMENTAL

BHR Case

Intervention Type OTHER

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control

During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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.

Cecile BOURGAIN, MD

Role: PRINCIPAL_INVESTIGATOR

AURA Paris Plaisance

Locations

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