Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients

Chronic Kidney Diseases Clinical Trial

— DIACOBHR  

Official title:

Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699682
• Other study ID #: DIACOBHR
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: March 14, 2025

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: Cecile BOURGAIN, MD
• Phone: 181696103
• Email: cecile.bourgain[@]auraparis.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 14, 2025
• Est. primary completion date: January 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Control
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).

Locations

Country	Name	City	State
France	AURA Bichat	Paris	Groupe Hospitalier Paris Saint-Joseph
France	AURA Corentin Celton	Paris	Groupe Hospitalier Paris Saint-Joseph
France	AURA Paris Plaisance	Paris	Groupe Hospitalier Paris Saint-Joseph
France	AURA Paris Site de Saint Ouen	Paris	Groupe Hospitalier Paris Saint-Joseph
France	Groupe Hospitalier Paris Saint-Joseph	Paris	Groupe Hospitalier Paris Saint-Joseph

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (3)

Davido B, Moussiegt A, Dinh A, Bouchand F, Matt M, Senard O, Deconinck L, Espinasse F, Lawrence C, Fortineau N, Saleh-Mghir A, Caballero S, Escaut L, Salomon J. Germs of thrones - spontaneous decolonization of Carbapenem-Resistant Enterobacteriaceae (CRE) — View Citation

Fournier S, Brossier F, Fortineau N, Gillaizeau F, Akpabie A, Aubry A, Barbut F, Chedhomme FX, Kassis-Chikhani N, Lucet JC, Robert J, Seytre D, Simon I, Vanjak D, Zahar JR, Brun-Buisson C, Jarlier V. Long-term control of vancomycin-resistant Enterococcus — View Citation

Zahar JR, Garrouste-Orgeas M, Vesin A, Schwebel C, Bonadona A, Philippart F, Ara-Somohano C, Misset B, Timsit JF. Impact of contact isolation for multidrug-resistant organisms on the occurrence of medical errors and adverse events. Intensive Care Med. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with disappearance of Carriage of bacteria	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	Prevalence of BHR carriage	This outcome corresponds to the proportion of patients with emerging highly resistant bacteria.	Year 1
Secondary	Comparison of Prevalence of BHR carriage between the 2 groups	This outcome corresponds to the comparison of carriage of emerging highly resistant bacteria between case patients and control patients.	Year 1