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Completed

NCT Number: NCT04085380

Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE)

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

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Key information

Conditions

Risk Factor

Sex eligibility

All sexes

Study type

Observational

Primary location

HEGP

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Hospitalization in psychiatry
  • Unwilling to participate

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Direction Générale de l'Offre de Soins

Registry information

Official study title

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

Acronym: CODBAHRE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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