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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
Sponsor:
Collaborator:
Direction Générale de l'Offre de Soins
Information provided by (Responsible Party):
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

Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. Description of the association between strains (RAPD, infrared Biotyper, genome sequencing). [ Time Frame: 16 months ]
    Identify possible links between strains

  7. 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.

  8. 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
Rectal swab


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hospitalization in psychiatry
  • Unwilling to participate

Information from the National Library of Medicine

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


Contacts
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Contact: Najiby Kassis-Chikhani, PhD 01 56 09 29 73 najiby.kassis-chikhani@aphp.fr
Contact: Patrick Grohs, PhD 01 56 09 38 44 patrick.grohs@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Direction Générale de l'Offre de Soins
Investigators
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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

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04085380     History of Changes
Other Study ID Numbers: CODBAHRE
APHP180561 ( Other Identifier: AP-HP )
2019-A01226-51 ( Other Identifier: IDRCB )
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: one year after the last publication
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


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Clostridium difficile
Multidrug resistant bacteria
Risks factor
highly resistant bacteria
eXDR
ESBL