Clinical trial NCT04085380: Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE)
Official title: Identification of New Highly Antibiotic-resistant Bacteria Carriage Risk Factors to Optimize the Detection and Medical Care for Carriers Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Factor
Keywords: Clostridium difficile
Multidrug resistant bacteria
Risks factor
highly resistant bacteria
eXDR
ESBL
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2019-09-11
Enrollment: 2396
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Hospitalization in psychiatry
* Unwilling to participate

Primary outcomes:
measure: Risk factors
timeFrame: at inclusion
Secondary outcomes:
measure: 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
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: Prevalence will be determined by the number of patients who carrying at least one Multidrug-resistant bacteria referred to the number of patients sampled
timeFrame: 1 day
measure: Proportion of patients carrying "eXDR" who will develop an infection with the same germ referred to the number of eXDR carriers
timeFrame: 6 months
measure: Cross-transmission rate of eXDR
timeFrame: 1 day
measure: Description of the association between strains (RAPD, infrared Biotyper, genome sequencing).
timeFrame: 16 months
measure: Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).
timeFrame: 16 months
measure: Comparison of the frequency of positive presence of eXDR bacteria obtained between culture technic and molecular biology technic
timeFrame: 16 months
Other outcomes:
Locations:
city: Paris
country: France
facility: HEGP
Study officials:
affiliation: AP-HP, Hôpital Européen Georges Pompidou, Paris
name: Najiby Kassis-Chikhani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP, Hôpitaux Avicenne, Jean Verdier, et René Muret, Bobigny
name: Jean-Ralph Zahar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP, Hôpital Corentin Celton, et Vaugirard
name: Véronique Moulin
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP, Hôpital Necker enfants malades, Paris
name: Pierre Frange, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP, Hôpital Raymond Poincaré, Garches
name: Christine Lawrence, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP-Hôpital Saint Antoine, Paris
name: Frédéric Barbut, PhD
role: PRINCIPAL_INVESTIGATOR
References: