Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients

NCT04699682 | Unknown

• 1 other identifier: DIACOBHR
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Kidney Diseases; Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prevalence of BHR carriage

  Year 1

• Comparison of Prevalence of BHR carriage between the 2 groups

  Year 1

Study Arms (2)

Control

EXPERIMENTAL

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

Other: Control

BHR Case

EXPERIMENTAL

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

Interventions

Control OTHER

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

Control

BHR Case 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).

BHR Case

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (5)

AURA Corentin Celton

Paris, Groupe Hospitalier Paris Saint-Joseph, 75014, France

RECRUITING

AURA Paris Plaisance

Paris, Groupe Hospitalier Paris Saint-Joseph, 75014, France

RECRUITING

AURA Paris Site de Saint Ouen

Paris, Groupe Hospitalier Paris Saint-Joseph, 75014, France

RECRUITING

Groupe Hospitalier Paris Saint-Joseph

Paris, Groupe Hospitalier Paris Saint-Joseph, 75014, France

RECRUITING

AURA Bichat

Paris, Groupe Hospitalier Paris Saint-Joseph, 75018, France

RECRUITING

Related Publications (3)

• 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 faecium at the scale of a large multihospital institution: a seven-year experience. Euro Surveill. 2012 Jul 26;17(30):20229.

  PMID: 22856512 RESULT

• 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) and Vancomycin-Resistant Enterococci (VRE) in Western Europe: is this myth or reality? Antimicrob Resist Infect Control. 2018 Aug 13;7:100. doi: 10.1186/s13756-018-0390-5. eCollection 2018.

  PMID: 30123500 RESULT

• 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. 2013 Dec;39(12):2153-60. doi: 10.1007/s00134-013-3071-0. Epub 2013 Aug 31.

  PMID: 23995982 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cecile BOURGAIN, MD

  AURA Paris Plaisance

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecile BOURGAIN, MD

CONTACT

181696103; cecile.bourgain@auraparis.org

Helene BEAUSSIER, PharmD, pHD

CONTACT

144127883; crc@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 7, 2021
• Study Start: March 15, 2021
• Primary Completion: January 14, 2024
• Study Completion: March 14, 2025
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

FR (5)