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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01591538
Other study ID # DAV148-EPI-01
Secondary ID ID RCB number :
Status Completed
Phase N/A
First received May 2, 2012
Last updated May 28, 2014
Start date March 2012
Est. completion date December 2013

Study information

Verified date May 2014
Source Da Volterra
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Dysbiosis
  • Intestinal Bacteria Flora Disturbance

Locations

Country Name City State
France Centre d'épidémiologie et de santé publique des armées Saint Mandé cedex

Sponsors (1)

Lead Sponsor Collaborator
Da Volterra

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France 12 months No
Secondary Quantitative measurement of MDRGNB in fecal samples (expressed as log10 and percentage) of volunteers after staying 4-6 months outside France 12 months No
Secondary Quantitative variation of MDRGNB between the departure and return in volunteers 12 months No
Secondary PCR and sequencing of resistance genes from strains of interest 12 months No
Secondary Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France 12 months No
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