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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12). |
|
| 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of BHR carriage | This outcome corresponds to the proportion of patients with emerging highly resistant bacteria. | Year 1 |
| Comparison of Prevalence of BHR carriage between the 2 groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cecile BOURGAIN, MD | Contact | 181696103 | +33 | cecile.bourgain@auraparis.org |
| Helene BEAUSSIER, PharmD, pHD | Contact | 144127883 | +33 | crc@ghpsj.fr |
| Name | Affiliation | Role |
|---|---|---|
| Cecile BOURGAIN, MD | AURA Paris Plaisance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AURA Corentin Celton | Recruiting | Paris | Groupe Hospitalier Paris Saint-Joseph | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22856512 | Result | 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. | |
| 30123500 |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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:
|
|
This outcome corresponds to the comparison of carriage of emerging highly resistant bacteria between case patients and control patients.
| Year 1 |
| AURA Paris Plaisance | Recruiting | Paris | Groupe Hospitalier Paris Saint-Joseph | 75014 | France |
|
| AURA Paris Site de Saint Ouen | Recruiting | Paris | Groupe Hospitalier Paris Saint-Joseph | 75014 | France |
|
| Groupe Hospitalier Paris Saint-Joseph | Recruiting | Paris | Groupe Hospitalier Paris Saint-Joseph | 75014 | France |
|
| AURA Bichat | Recruiting | Paris | Groupe Hospitalier Paris Saint-Joseph | 75018 | France |
|
| 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. |
| 23995982 | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |