Risk FactorCODBAHRENCT04085380
Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE)
An observational study of Risk Factor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to identify in hospitalized patients, the risk factors associated with the digestive colonisation by emergent extensively drug-resistant bacteria (eXDR), to optimize their detection and the medical care for carriers these patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Risk Factor
- How many people
- 2,396 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2019to 10 Jul 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient hospitalized more than 24 hours, on a given day in one of the participating hospitals, is eligible to be included in the protocol, unless hospitalized in psychiatry
Who may be able to join
- Hospitalization of more than 24 hours
- Give his no objection
Who cannot join
- Hospitalization in psychiatry
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of New Highly Antibiotic-resistant Bacteria Carriage Risk Factors to Optimize the Detection and Medical Care for Carriers Patients
The aim of this study is to identify in hospitalized patients, the risk factors associated with the digestive colonisation by emergent extensively drug-resistant bacteria (eXDR), to optimize their detection and the medical care for carriers these patients
Read the detailed description
CODBAHRE is a french, regional study, involving 9 centers. Recruitment will take place in all the departments of the centers involved under the supervision of the Infection Control Team.
All patients hospitalized more than 24 hours, on a given day are eligible for the protocol, except the patients unable to answer the questionnaire.
After collecting the non-opposition of the patient, patients will be screened by rectal swab and a questionnaire will be completed.
Each sample will be analyzed to detect eXDR carrying patients.
The carrying patients will be followed during 6 months to estimate the proportion of the population which developped a bacterial infection. This information will be collected by a retrospective telephone survey of carrying patients.
- Conditions
- Risk Factor
- Keywords
- Clostridium difficile, Multidrug resistant bacteria, Risks factor, highly resistant bacteria, eXDR, ESBL
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors
Identification of risk factors for digestive colonisation by highly resistant bacteria Lifestyle questionnaire: environment, diet, medical history and result of the rectal swab
Measured: at inclusion
Secondary outcomes (8)
Prevalence of multidrug-resistant bacteria will be determined by the number of patients who have been detected at least one multidrug-resistant bacteria referred to the number of patients sampled
Number of patient carrying a Multidrug-resistant bacteria in Ile de France
Measured: 1 day
Prevalence of co-carrying patients of eXDR and ESBL will be determined by the number of patients who carrying eXDR and ESBL referred to the number of patients sampled
Estimate the prevalence of "co-carrying patients of eXDR and ESBL in the Ile de France
Measured: 1 day
Prevalence will be determined by the number of patients who carrying at least one Multidrug-resistant bacteria referred to the number of patients sampled
Establish whether there are significant differences between hospital associated with the recruitment of these institutions.
Measured: 1 day
Proportion of patients carrying "eXDR" who will develop an infection with the same germ referred to the number of eXDR carriers
Estimate the proportion of patients colonized by a "eXDR" who will develop an infection with the same germ.
Measured: 6 months
Cross-transmission rate of eXDR
Number of cross transmissions during the study by comparing the eXDR bacteria genotypes in the same unit
Measured: 1 day
Description of the association between strains (RAPD, infrared Biotyper, genome sequencing).
Identify possible links between strains
Measured: 16 months
Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).
Characterize the resistance and virulence factors of certain strains.
Measured: 16 months
Comparison of the frequency of positive presence of eXDR bacteria obtained between culture technic and molecular biology technic
Comparison culture vs molecular biology technics.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start16 Sep 2019
- Primary completion16 Jan 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk FactorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Najiby Kassis-Chikhani, PhD, Principal investigator, AP-HP, Hôpital Européen Georges Pompidou, ParisJean-Ralph Zahar, PhD, Principal investigator, AP-HP, Hôpitaux Avicenne, Jean Verdier, et René Muret, BobignyVéronique Moulin, Principal investigator, AP-HP, Hôpital Corentin Celton, et VaugirardPierre Frange, PhD, Principal investigator, AP-HP, Hôpital Necker enfants malades, ParisChristine Lawrence, PhD, Principal investigator, AP-HP, Hôpital Raymond Poincaré, GarchesFrédéric Barbut, PhD, Principal investigator, AP-HP-Hôpital Saint Antoine, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085380
- Sponsor's protocol ID
- CODBAHRE
- Other IDs
- APHP180561, 2019-A01226-51
- Acronym
- CODBAHRE
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Highly Antibiotic-resistant Bacteria Carriage Risk Factors to Optimize the Detection and Medical Care for Carriers Patients
- ClinicalTrials.gov ID
- NCT04085380
- Acronym / sponsor ID
- CODBAHRE / CODBAHRE
- Conditions
- Risk Factor
- Keywords
- Clostridium difficile, Multidrug resistant bacteria, Risks factor, highly resistant bacteria, eXDR, ESBL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,396 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 11 Sep 2019 (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 aim of this study is to identify in hospitalized patients, the risk factors associated with the digestive colonisation by emergent extensively drug-resistant bacteria (eXDR), to optimize their detection and the medical care for carriers these patients
Detailed description
CODBAHRE is a french, regional study, involving 9 centers. Recruitment will take place in all the departments of the centers involved under the supervision of the Infection Control Team.
All patients hospitalized more than 24 hours, on a given day are eligible for the protocol, except the patients unable to answer the questionnaire.
After collecting the non-opposition of the patient, patients will be screened by rectal swab and a questionnaire will be completed.
Each sample will be analyzed to detect eXDR carrying patients.
The carrying patients will be followed during 6 months to estimate the proportion of the population which developped a bacterial infection. This information will be collected by a retrospective telephone survey of carrying patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient hospitalized more than 24 hours, on a given day in one of the participating hospitals, is eligible to be included in the protocol, unless hospitalized in psychiatry
Key inclusion criteria (2 listed)
- Hospitalization of more than 24 hours
- Give his no objection
Key exclusion criteria (2 listed)
- Hospitalization in psychiatry
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors
Time frame: at inclusion
Identification of risk factors for digestive colonisation by highly resistant bacteria Lifestyle questionnaire: environment, diet, medical history and result of the rectal swab
8 secondary outcomes
Prevalence of multidrug-resistant bacteria will be determined by the number of patients who have been detected at least one multidrug-resistant bacteria referred to the number of patients sampled
Time frame: 1 day
Prevalence of co-carrying patients of eXDR and ESBL will be determined by the number of patients who carrying eXDR and ESBL referred to the number of patients sampled
Time frame: 1 day
Prevalence will be determined by the number of patients who carrying at least one Multidrug-resistant bacteria referred to the number of patients sampled
Time frame: 1 day
Proportion of patients carrying "eXDR" who will develop an infection with the same germ referred to the number of eXDR carriers
Time frame: 6 months
Cross-transmission rate of eXDR
Time frame: 1 day
Description of the association between strains (RAPD, infrared Biotyper, genome sequencing).
Time frame: 16 months
Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).
Time frame: 16 months
Comparison of the frequency of positive presence of eXDR bacteria obtained between culture technic and molecular biology technic
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Yes
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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.
Najiby Kassis-Chikhani, PhD principal investigator
AP-HP, Hôpital Européen Georges Pompidou, Paris
Jean-Ralph Zahar, PhD principal investigator
AP-HP, Hôpitaux Avicenne, Jean Verdier, et René Muret, Bobigny
Véronique Moulin principal investigator
AP-HP, Hôpital Corentin Celton, et Vaugirard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factor, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2020.