Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE) (CODBAHRE)
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|ClinicalTrials.gov Identifier: NCT04085380|
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
|Condition or disease|
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|
|Estimated Enrollment :||3000 participants|
|Official Title:||Identification of New Highly Antibiotic-resistant Bacteria Carriage Risk Factors to Optimize the Detection and Medical Care for Carriers Patients|
|Estimated Study Start Date :||September 16, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||January 15, 2021|
- Risk factors [ Time Frame: 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
- 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 [ Time Frame: 1 day ]Number of patient carrying a Multidrug-resistant bacteria in Ile de France
- 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 [ Time Frame: 1 day ]Estimate 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 sampled [ Time Frame: 1 day ]Establish 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 carriers [ Time Frame: 6 months ]Estimate the proportion of patients colonized by a "eXDR" who will develop an infection with the same germ.
- Cross-transmission rate of eXDR [ Time Frame: 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). [ Time Frame: 16 months ]Identify possible links between strains
- Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing). [ Time Frame: 16 months ]Characterize 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 technic [ Time Frame: 16 months ]Comparison culture vs molecular biology technics.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085380
|Contact: Najiby Kassis-Chikhani, PhD||01 56 09 29 firstname.lastname@example.org|
|Contact: Patrick Grohs, PhD||01 56 09 38 email@example.com|
|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|