- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01985217
Prevalence of Digestive Carriage of Integrons (APIHA)
Prevalence of Digestive Carriage of Integrons to Resistance in Two Populations in Limousin
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Limoges, France
- Service de Virologie
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive PCR
Time Frame: day 1
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|
day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- I07020
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