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Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE)

Identification of New Highly Antibiotic-resistant Bacteria Carriage Risk Factors to Optimize the Detection and Medical Care for Carriers Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04085380
Acronym
CODBAHRE
Enrollment
2396
Registered
2019-09-11
Start date
2019-09-16
Completion date
2020-07-10
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk Factor

Keywords

Clostridium difficile, Multidrug resistant bacteria, Risks factor, highly resistant bacteria, eXDR, ESBL

Brief 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

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.

Interventions

None listed

Sponsors

Direction Générale de l'Offre de Soins
CollaboratorOTHER_GOV
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Hospitalization of more than 24 hours * Give his no objection

Exclusion criteria

* Hospitalization in psychiatry * Unwilling to participate

Design outcomes

Primary

MeasureTime frameDescription
Risk factorsat inclusionIdentification of risk factors for digestive colonisation by highly resistant bacteria Lifestyle questionnaire: environment, diet, medical history and result of the rectal swab

Secondary

MeasureTime frameDescription
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 sampled1 dayEstimate the prevalence of co-carrying patients of eXDR and ESBL in the Ile de France
Prevalence will be determined by the number of patients who carrying at least one Multidrug-resistant bacteria referred to the number of patients sampled1 dayEstablish whether there are significant differences between hospital associated with the recruitment of these institutions.
Proportion of patients carrying eXDR who will develop an infection with the same germ referred to the number of eXDR carriers6 monthsEstimate the proportion of patients colonized by a eXDR who will develop an infection with the same germ.
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 sampled1 dayNumber of patient carrying a Multidrug-resistant bacteria in Ile de France
Description of the association between strains (RAPD, infrared Biotyper, genome sequencing).16 monthsIdentify possible links between strains
Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).16 monthsCharacterize the resistance and virulence factors of certain strains.
Comparison of the frequency of positive presence of eXDR bacteria obtained between culture technic and molecular biology technic16 monthsComparison culture vs molecular biology technics.
Cross-transmission rate of eXDR1 dayNumber of cross transmissions during the study by comparing the eXDR bacteria genotypes in the same unit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026