Multi-Antibiotic Resistance Carriage in Gut Flora

Intestinal Bacteria Flora Disturbance Clinical Trial

— MARC  

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

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