Chronic Kidney DiseasesDIACOBHRNCT04699682
Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients
A study testing BHR Case in people with Chronic Kidney Diseases and Dialysis, run by Fondation Hôpital Saint-Joseph at 5 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Dialysis
- What is being tested?
- BHR Case
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesFrance
- Study dates
- 15 Mar 2021to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Pregnant or breastfeeding woman
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
AURA Corentin Celton
Paris, Groupe Hospitalier Paris Saint-Joseph, 75014
Cecile BOURGAIN, MD, cecile.bourgain@auraparis.org
- Recruiting
AURA Paris Plaisance
Paris, Groupe Hospitalier Paris Saint-Joseph, 75014
Cecile BOURGAIN, MD, 181696103 ext. +33, cecile.bourgain@auraparis.org
Cecile BOURGAIN, MD
- Recruiting
AURA Paris Site de Saint Ouen
Paris, Groupe Hospitalier Paris Saint-Joseph, 75014
Pablo URENA, MD, pablo.urena@auraparis.org
Pablo URENA, MD
- Recruiting
Groupe Hospitalier Paris Saint-Joseph
Paris, Groupe Hospitalier Paris Saint-Joseph, 75014
Benoit PILMIS, MD, 144127820, bpilmis@ghpsj.fr
Benoit PILMIS, MD
- Recruiting
AURA Bichat
Paris, Groupe Hospitalier Paris Saint-Joseph, 75018
Cecile BOURGAIN, MD, cecile.bourgain@auraparis.org
About this study
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.
Read more
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
- Being tested
- Control, BHR Case
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).
BHR CaseOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12). Receives: 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). Receives: Other: BHR Case |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 1
Secondary outcomes (2)
Prevalence of BHR carriage
This outcome corresponds to the proportion of patients with emerging highly resistant bacteria.
Measured: 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.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start15 Mar 2021
- Primary completion14 Jan 2024 (estimated)
- Study completion14 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecile BOURGAIN, MD, Principal investigator, AURA Paris Plaisance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699682
- Sponsor's protocol ID
- DIACOBHR
- Acronym
- DIACOBHR
- Status last verified
- Apr 2023
- First submitted
- 30 Dec 2020
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22856512Davido 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.
PubMed 30123500Zahar 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.
PubMed 23995982
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients
- ClinicalTrials.gov ID
- NCT04699682
- Acronym / sponsor ID
- DIACOBHR / DIACOBHR
- Conditions
- Chronic Kidney Diseases, Dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 14 Jan 2024 (estimated)
- Study completion
- 14 Mar 2025 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlDuring follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12). |
| BHR Case | Experimental | Other: BHR CaseDuring 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlDuring follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12). | Other | Control |
| BHR CaseDuring 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 |
Primary outcome
Number of Participants with disappearance of Carriage of bacteria
Time frame: Year 1
This outcome corresponds to the disappearance of the carriage of the emerging highly resistant bacteria over the follow-up period of one year.
2 secondary outcomes
Prevalence of BHR carriage
Time frame: Year 1
Comparison of Prevalence of BHR carriage between the 2 groups
Time frame: Year 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Results publication: PubMed 22856512Fournier 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 publication: PubMed 30123500Davido 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 publication: PubMed 23995982Zahar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecile BOURGAIN, MD principal investigator
AURA Paris Plaisance
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BHR Case in people with Chronic Kidney Diseases and Dialysis, run by Fondation Hôpital Saint-Joseph at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecile BOURGAIN, MD (181696103 ext. +33, cecile.bourgain@auraparis.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with disappearance of Carriage of bacteria (time frame: Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699682, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.