Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE)

Completed

• Conditions: Risk Factor

• Registration Number: NCT04085380
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Study Start: 2019-09-16
• Primary Completion: 2020-01-16
• Study Completion: 2020-07-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2396

Inclusion Criteria

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

Exclusion Criteria

• Hospitalization in psychiatry
• Unwilling to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors	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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients carrying "eXDR" who will develop an infection with the same germ referred to the number of eXDR carriers	6 months	Estimate the proportion of patients colonized by a "eXDR" who will develop an infection with the same germ.
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	1 day	Estimate the prevalence of "co-carrying patients of eXDR and ESBL in the Ile de France
Cross-transmission rate of eXDR	1 day	Number of cross transmissions during the study by comparing the eXDR bacteria genotypes in the same unit
Description of the association between strains (RAPD, infrared Biotyper, genome sequencing).	16 months	Identify possible links between strains
Comparison of the frequency of positive presence of eXDR bacteria obtained between culture technic and molecular biology technic	16 months	Comparison culture vs molecular biology technics.
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	1 day	Number of patient carrying a Multidrug-resistant bacteria in Ile de France
Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).	16 months	Characterize the resistance and virulence factors of certain strains.
Prevalence will be determined by the number of patients who carrying at least one Multidrug-resistant bacteria referred to the number of patients sampled	1 day	Establish whether there are significant differences between hospital associated with the recruitment of these institutions.

Trial Locations

Locations (1)

HEGP; 🇫🇷 Paris, France