Multi-Antibiotic Resistance Carriage in Gut Flora (MARC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Da Volterra
ClinicalTrials.gov Identifier:
NCT01591538
First received: May 2, 2012
Last updated: May 28, 2014
Last verified: May 2014
  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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Da Volterra
ClinicalTrials.gov Identifier: NCT01591538     History of Changes
Other Study ID Numbers: DAV148-EPI-01, ID RCB number : 2011-A01569-32
Study First Received: May 2, 2012
Last Updated: May 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Dysbiosis
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014