Multi-Antibiotic Resistance Carriage in Gut Flora

NCT ID: NCT01591538

Last Updated: 2014-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

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.

Conditions

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Intestinal Bacteria Flora Disturbance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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lifestyle condition

No interventions assigned to this group

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Da Volterra

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Baptiste MEYNARD, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

French Armed Forces

Locations

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Centre d'épidémiologie et de santé publique des armées

Saint-Mandé, , France

Site Status

Countries

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France

Other Identifiers

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ID RCB number : 2011-A01569-32

Identifier Type: OTHER

Identifier Source: secondary_id

DAV148-EPI-01

Identifier Type: -

Identifier Source: org_study_id

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