Multi-Antibiotic Resistance Carriage in Gut Flora

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Intestinal Bacteria Flora Disturbance

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lifestyle condition<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France |  | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevalence, MDRGNB, Acquisition, Middle stay, Endemic area