Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients (DIACOBHR)
Primary Purpose
Chronic Kidney Diseases, Dialysis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Control
BHR Case
Sponsored by
About this trial
This is an interventional other trial for Chronic Kidney Diseases
Eligibility Criteria
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
Sites / Locations
- AURA Corentin CeltonRecruiting
- AURA Paris PlaisanceRecruiting
- AURA Paris Site de Saint OuenRecruiting
- Groupe Hospitalier Paris Saint-JosephRecruiting
- AURA BichatRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control
BHR Case
Arm Description
During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Prevalence of BHR carriage
This outcome corresponds to the proportion of patients with emerging highly resistant bacteria.
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.
Full Information
NCT ID
NCT04699682
First Posted
December 30, 2020
Last Updated
April 13, 2023
Sponsor
Fondation Hôpital Saint-Joseph
1. Study Identification
Unique Protocol Identification Number
NCT04699682
Brief Title
Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients
Acronym
DIACOBHR
Official Title
Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
January 14, 2024 (Anticipated)
Study Completion Date
March 14, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Dialysis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).
Arm Title
BHR Case
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Control
Intervention Description
During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).
Intervention Type
Other
Intervention Name(s)
BHR Case
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Participants with disappearance of Carriage of bacteria
Description
This outcome corresponds to the disappearance of the carriage of the emerging highly resistant bacteria over the follow-up period of one year.
Time Frame
Year 1
Secondary Outcome Measure Information:
Title
Prevalence of BHR carriage
Description
This outcome corresponds to the proportion of patients with emerging highly resistant bacteria.
Time Frame
Year 1
Title
Comparison of Prevalence of BHR carriage between the 2 groups
Description
This outcome corresponds to the comparison of carriage of emerging highly resistant bacteria between case patients and control patients.
Time Frame
Year 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecile BOURGAIN, MD
Phone
181696103
Ext
+33
Email
cecile.bourgain@auraparis.org
First Name & Middle Initial & Last Name or Official Title & Degree
Helene BEAUSSIER, PharmD, pHD
Phone
144127883
Ext
+33
Email
crc@ghpsj.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecile BOURGAIN, MD
Organizational Affiliation
AURA Paris Plaisance
Official's Role
Principal Investigator
Facility Information:
Facility Name
AURA Corentin Celton
City
Paris
State/Province
Groupe Hospitalier Paris Saint-Joseph
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile BOURGAIN, MD
Email
cecile.bourgain@auraparis.org
Facility Name
AURA Paris Plaisance
City
Paris
State/Province
Groupe Hospitalier Paris Saint-Joseph
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile BOURGAIN, MD
Phone
181696103
Ext
+33
Email
cecile.bourgain@auraparis.org
First Name & Middle Initial & Last Name & Degree
Cecile BOURGAIN, MD
Facility Name
AURA Paris Site de Saint Ouen
City
Paris
State/Province
Groupe Hospitalier Paris Saint-Joseph
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo URENA, MD
Email
pablo.urena@auraparis.org
First Name & Middle Initial & Last Name & Degree
Pablo URENA, MD
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
State/Province
Groupe Hospitalier Paris Saint-Joseph
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit PILMIS, MD
Phone
144127820
Email
bpilmis@ghpsj.fr
First Name & Middle Initial & Last Name & Degree
Benoit PILMIS, MD
Facility Name
AURA Bichat
City
Paris
State/Province
Groupe Hospitalier Paris Saint-Joseph
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile BOURGAIN, MD
Email
cecile.bourgain@auraparis.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
22856512
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 faecium at the scale of a large multihospital institution: a seven-year experience. Euro Surveill. 2012 Jul 26;17(30):20229.
Results Reference
result
PubMed Identifier
30123500
Citation
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.
Results Reference
result
PubMed Identifier
23995982
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. 2013 Dec;39(12):2153-60. doi: 10.1007/s00134-013-3071-0. Epub 2013 Aug 31.
Results Reference
result
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Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients
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