Informations générales (source: ClinicalTrials.gov)
Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients (DIACOBHR)
Interventional
N/A
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
mars 2021
mars 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Benoit PILMIS, MD | Contact (sur clinicalTrials) | |||
| UNITE DE DIALYSE SITE AURA BICHAT | Cecile BOURGAIN, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AURA Corentin Celton - 75014 - Paris - Groupe Hospitalier Paris Saint-Joseph - France | Cecile BOURGAIN, MD | Contact (sur clinicalTrials) | |||
| AURA Paris Plaisance - 75014 - Paris - Groupe Hospitalier Paris Saint-Joseph - France | Cecile BOURGAIN, MD | Contact (sur clinicalTrials) | |||
| AURA Paris Site de Saint Ouen - 75014 - Paris - Groupe Hospitalier Paris Saint-Joseph - France | Pablo URENA, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Pregnant or breastfeeding woman