Multi-Antibiotic Resistance Carriage in Gut Flora

Completed

• Conditions: Intestinal Bacteria Flora Disturbance

• Registration Number: NCT01591538
• Lead Sponsor: Da Volterra

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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre d'épidémiologie et de santé publique des armées; 🇫🇷 Saint Mandé cedex, France