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OpenTrials
Completed

NCT Number: NCT01985217

Prevalence of Digestive Carriage of Integrons

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Virologie

Limoges, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

Prevalence of Digestive Carriage of Integrons to Resistance in Two Populations in Limousin

Acronym: APIHA

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Nov 15, 2013
Registry last updated
Nov 15, 2013

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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