Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE) (CODBAHRE)

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

Study Overview

• Status: Completed
• Conditions: Risk Factor

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 Type: Observational
• Enrollment (Actual): 2396

Contacts and Locations

Study Locations

• France
  • Paris, France
    • HEGP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Hospitalization in psychiatry
• Unwilling to participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Cross-transmission rate of eXDR	Number of cross transmissions during the study by comparing the eXDR bacteria genotypes in the same unit	1 day
Description of the association between strains (RAPD, infrared Biotyper, genome sequencing).	Identify possible links between strains	16 months
Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).	Characterize the resistance and virulence factors of certain strains.	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.	16 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Direction Générale de l'Offre de Soins
• Investigators: Principal Investigator: Najiby Kassis-Chikhani, PhD, AP-HP, Hôpital Européen Georges Pompidou, Paris; Principal Investigator: Jean-Ralph Zahar, PhD, AP-HP, Hôpitaux Avicenne, Jean Verdier, et René Muret, Bobigny; Principal Investigator: Véronique Moulin, AP-HP, Hôpital Corentin Celton, et Vaugirard; Principal Investigator: Pierre Frange, PhD, AP-HP, Hôpital Necker enfants malades, Paris; Principal Investigator: Christine Lawrence, PhD, AP-HP, Hôpital Raymond Poincaré, Garches; Principal Investigator: Frédéric Barbut, PhD, AP-HP-Hôpital Saint Antoine, Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): January 16, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Clostridium difficile; ESBL; Multidrug resistant bacteria; Risks factor; highly resistant bacteria; eXDR
• Other Study ID Numbers: CODBAHRE; APHP180561 (Other Identifier: AP-HP); 2019-A01226-51 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: one year after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.

Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No