Multi-Antibiotic Resistance Carriage in Gut Flora (MARC)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease
Intestinal Bacteria Flora Disturbance

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	272 participants
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
Study Start Date :	March 2012
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Groups and Cohorts

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Group/Cohort
lifestyle condition

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. 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 ]
2. Quantitative variation of MDRGNB between the departure and return in volunteers [ Time Frame: 12 months ]
3. PCR and sequencing of resistance genes from strains of interest [ Time Frame: 12 months ]
4. 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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 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