Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE)

Risk Factor Clinical Trial

— CODBAHRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085380
• Other study ID #: CODBAHRE
• Secondary ID: APHP1805612019-A
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: July 10, 2020

Study information

• Verified date: October 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2396
• Est. completion date: July 10, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hospitalization of more than 24 hours

• Give his no objection

Exclusion Criteria:

• Hospitalization in psychiatry

• Unwilling to participate

Related Conditions & MeSH terms

• Risk Factor

Locations

Country	Name	City	State
France	HEGP	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Direction Générale de l'Offre de Soins

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at inclusion
Secondary	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	1 day
Secondary	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	1 day
Secondary	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.	1 day
Secondary	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.	6 months
Secondary	Cross-transmission rate of eXDR	Number of cross transmissions during the study by comparing the eXDR bacteria genotypes in the same unit	1 day
Secondary	Description of the association between strains (RAPD, infrared Biotyper, genome sequencing).	Identify possible links between strains	16 months
Secondary	Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).	Characterize the resistance and virulence factors of certain strains.	16 months
Secondary	Comparison of the frequency of positive presence of eXDR bacteria obtained between culture technic and molecular biology technic	Comparison culture vs molecular biology technics.	16 months