Clinical trial NCT01591538: Multi-Antibiotic Resistance Carriage in Gut Flora
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Bacteria Flora Disturbance
Keywords: Prevalence
MDRGNB
Acquisition
Middle stay
Endemic area
Lead sponsor: Da Volterra
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers from French Armed Forces

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.

Eligibility 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.

Primary outcomes:
measure: Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France
timeFrame: 12 months
Secondary outcomes:
measure: Quantitative measurement of MDRGNB in fecal samples (expressed as log10 and percentage) of volunteers after staying 4-6 months outside France
timeFrame: 12 months
measure: Quantitative variation of MDRGNB between the departure and return in volunteers
timeFrame: 12 months
measure: PCR and sequencing of resistance genes from strains of interest
timeFrame: 12 months
measure: Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Mandé cedex
country: France
facility: Centre d'épidémiologie et de santé publique des armées
Study officials:
affiliation: French Armed Forces
name: Jean-Baptiste MEYNARD, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: