An interventional study of Control and BHR Case in Chronic Kidney Diseases and Dialysis, sponsored by Fondation Hôpital Saint-Joseph. Status unknown at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by Fondation Hôpital Saint-Joseph · Not applicable, Interventional, and Other
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:
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 600 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).
Other: Control
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
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).
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.
Time frame: Year 1
Prevalence of BHR carriage
This outcome corresponds to the proportion of patients with emerging highly resistant bacteria.
Time frame: Year 1
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.
Time frame: Year 1
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Fondation Hôpital Saint-Joseph