Multi-Antibiotic Resistance Carriage in Gut Flora (MARC)

This study is currently recruiting participants.
Verified May 2012 by Da Volterra
Sponsor:
Information provided by (Responsible Party):
Da Volterra
ClinicalTrials.gov Identifier:
NCT01591538
First received: May 2, 2012
Last updated: May 3, 2012
Last verified: May 2012

May 2, 2012
May 3, 2012
March 2012
December 2012   (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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01591538 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
  • Quantitative variation of MDRGNB between the departure and return in volunteers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • PCR and sequencing of resistance genes from strains of interest [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Stool

Non-Probability Sample

Volunteers from French Armed Forces

Intestinal Bacteria Flora Disturbance
Not Provided
lifestyle condition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
272
April 2013
December 2012   (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.
Both
18 Years and older
Yes
Contact: Annie DUCHER, MD +33 1 1 58 39 32 20 annie.ducher@davolterra.com
France
 
NCT01591538
DAV148-EPI-01, ID RCB number : 2011-A01569-32
No
Da Volterra
Da Volterra
Not Provided
Principal Investigator: Jean-Baptiste MEYNARD, MD/PhD French Armed Forces
Da Volterra
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP