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Prevalence of Digestive Carriage of Integrons (APIHA)

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ClinicalTrials.gov Identifier: NCT01985217
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Tracking Information
First Submitted Date November 4, 2013
First Posted Date November 15, 2013
Last Update Posted Date November 15, 2013
Study Start Date August 2009
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 8, 2013)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Digestive Carriage of Integrons
Official Title Prevalence of Digestive Carriage of Integrons to Resistance in Two Populations in Limousin
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.
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 Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population people working in the hospital kitchen
Condition Bacterial Resistance to Antimicrobial
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 8, 2013)
492
Original Actual Enrollment Same as current
Study Completion Date December 2013
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01985217
Other Study ID Numbers I07020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Limoges
Study Sponsor University Hospital, Limoges
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Limoges
Verification Date November 2013