APIHA: Prevalence of Digestive Carriage of Integrons

Sponsor
University Hospital, Limoges (Other)
Overall Status
Completed
CT.gov ID
NCT01985217
Collaborator
(none)
492
1
52
9.5

Study Details

Study Description

Brief Summary

Bacterial resistance to antimicrobials is an increasing problem. Doctors occasionally face genuine therapeutic dead-ends, when attempting to cure nosocomial infections and, more and more frequently, community-acquired infections. Mastering antimicrobial resistance diffusion is nowadays a major Public Health issue.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Struggling against bacterial resistance to antimicrobials lays on three main measures:
    • individual and collective hygiene.

    • proper antibiotics practices, which could help reduce antibiotic selective pressure.

    • better understanding of bacterial resistance mechanisms and resistance gene transfer between bacteria.

    Integrons, gene capture and expression systems, are recognised as major players in resistance gene transfer, which accounts for the greater part of resistance emergence and dissemination. Integrons are typically described in Gram negative bacteria, isolated in man, environmental settings and animals. They encode resistances to nearly every class of antimicrobials. A strong link between integrons and resistance to multiple antibiotic compounds has been described and integron detection is a relevant indicator of resistance to multiple antibiotics.

    The investigators project offers to study the impact of antibiotics on the frequency of integron intestinal carriage in the Limousin region and the genetic communities between the two groups.

    This study will use an innovative real-time PCR technique to detect integrons directly in the sample without using traditional culture-based techniques. The investigators hope to detect new integron-carriers, notably patients for whom integrons are borne by non or poorly cultivable bacteria. Stool samples will be taken from two groups of subjects : 246 intensive-care unit patients under high antibiotic selective pressure, compared with 246 healthy individuals representative of the community, under a more usual selective pressure. In both groups, antibiotic consumption will be fully documented.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    492 participants
    Time Perspective:
    Prospective
    Official Title:
    Prevalence of Digestive Carriage of Integrons to Resistance in Two Populations in Limousin
    Study Start Date :
    Aug 1, 2009
    Actual Primary Completion Date :
    Apr 1, 2012
    Study Completion Date :
    Dec 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Positive PCR [day 1]

      From the "conventional", a subject is found integrons carrying resistance when the PCR is positive on at least one bacterial strain previously isolated. According to the "direct" approach, a subject is considered integrons carrying resistance when the PCR is positive in the DNA extracted directly from feces or broth enrichment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • adults > 18 years

    • patients Hospitalized in intensive care unit for at least 48 hours, including one antibiotic was found at least in the background (<3 months).

    • patients followed by the Department for Work and Health for bacteriological examination of stool

    • possible information about antibiotic therapy provided

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Virologie Limoges France

    Sponsors and Collaborators

    • University Hospital, Limoges

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Limoges
    ClinicalTrials.gov Identifier:
    NCT01985217
    Other Study ID Numbers:
    • I07020
    First Posted:
    Nov 15, 2013
    Last Update Posted:
    Nov 15, 2013
    Last Verified:
    Nov 1, 2013

    Study Results

    No Results Posted as of Nov 15, 2013