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Prevalence of Digestive Carriage of Integrons (APIHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01985217
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Information provided by (Responsible Party):
University Hospital, Limoges

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
Bacterial Resistance to Antimicrobial

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.

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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 : August 2009
Actual Primary Completion Date : April 2012
Study Completion Date : December 2013

Primary Outcome Measures :
  1. Positive PCR [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
people working in the hospital kitchen

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

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 identifier (NCT number): NCT01985217

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Service de Virologie
Limoges, France
Sponsors and Collaborators
University Hospital, Limoges

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Responsible Party: University Hospital, Limoges Identifier: NCT01985217     History of Changes
Other Study ID Numbers: I07020
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013