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Multi-Antibiotic Resistance Carriage in Gut Flora (MARC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01591538
First Posted: May 4, 2012
Last Update Posted: May 29, 2014
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.
Information provided by (Responsible Party):
Da Volterra
  Purpose
Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6 months outside France.

Condition
Intestinal Bacteria Flora Disturbance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence Study Evaluating the Acquisition of Carriage of Resistant Bacteria in the Gut Flora in Volunteers From French Armed Forces Coming Back From External Operations

Further study details as provided by Da Volterra:

Primary Outcome Measures:
  • Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Quantitative measurement of MDRGNB in fecal samples (expressed as log10 and percentage) of volunteers after staying 4-6 months outside France [ Time Frame: 12 months ]
  • Quantitative variation of MDRGNB between the departure and return in volunteers [ Time Frame: 12 months ]
  • PCR and sequencing of resistance genes from strains of interest [ Time Frame: 12 months ]
  • Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France [ Time Frame: 12 months ]

Biospecimen Retention:   Samples Without DNA
Stool

Enrollment: 272
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
lifestyle condition

Detailed Description:
Emergence of MDRGN bacteria is blowing worldwide up leading to therapeutical failure in hospitalized patients with severe infections, as well as in outpatients with community-acquired infections such as UTI. Variation in prevalence exists across countries and regions. Travels outside own country of residence, like France, whatever the duration (short or long)or the reason (professional or leisure), are known risk factors for acquiring and disseminating MDRGN bacteria. Digestive carriage of multidrug-resistant Enterobacteriaceae could be a source of infection for the host as well as a source of dissemination. Qualitative and quantitative gut colonization by MDRGNB is poorly studied in non-hospitalized people who stayed for a few months out of France. The total amount of multidrug-resistant Enterobacteriaceae influences the spread of the dissemination. In our knowledge, no clinical study has been carried out to qualify and quantify gut colonization by MDRGNB in volunteers after staying 4-6 months outside country of residence such as France. A specific microbiological method will be evaluated in this study.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers from French Armed Forces
Criteria

Inclusion Criteria:

  • Being older than 18 years
  • Have given an informed consent by signing the written consent
  • Being able to give a stool sample
  • Being member of military forces, supported medically by the French Military Health Services (SSA), and to participate outside mission during 4- 6 months

Exclusion Criteria:

  • Participating in another biomedical study during the study
  • Volunteer unable to give informed consent.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01591538


Locations
France
Centre d'épidémiologie et de santé publique des armées
Saint Mandé cedex, France, 94163
Sponsors and Collaborators
Da Volterra
Investigators
Principal Investigator: Jean-Baptiste MEYNARD, MD/PhD French Armed Forces
  More Information

Responsible Party: Da Volterra
ClinicalTrials.gov Identifier: NCT01591538     History of Changes
Other Study ID Numbers: DAV148-EPI-01
ID RCB number : 2011-A01569-32 ( Other Identifier: AFSSAPS )
First Submitted: May 2, 2012
First Posted: May 4, 2012
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by Da Volterra:
Prevalence
MDRGNB
Acquisition
Middle stay
Endemic area

Additional relevant MeSH terms:
Dysbiosis
Pathologic Processes