Multi-Antibiotic Resistance Carriage in Gut Flora (MARC)

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: NCT01591538
Recruitment Status : Completed
First Posted : May 4, 2012
Last Update Posted : May 29, 2014
Information provided by (Responsible Party):
Da Volterra

May 2, 2012
May 4, 2012
May 29, 2014
March 2012
December 2013   (Final data collection date for primary outcome measure)
Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01591538 on Archive Site
  • 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 ]
Same as current
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Multi-Antibiotic Resistance Carriage in Gut Flora
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
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.
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.
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Non-Probability Sample
Volunteers from French Armed Forces
Intestinal Bacteria Flora Disturbance
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lifestyle condition
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
ID RCB number : 2011-A01569-32 ( Other Identifier: AFSSAPS )
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Da Volterra
Da Volterra
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Principal Investigator: Jean-Baptiste MEYNARD, MD/PhD French Armed Forces
Da Volterra
May 2014