Multi-Antibiotic Resistance Carriage in Gut Flora (MARC)
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| ClinicalTrials.gov Identifier: NCT01591538 |
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Recruitment Status :
Completed
First Posted : May 4, 2012
Last Update Posted : May 29, 2014
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Sponsor:
Da Volterra
Information provided by (Responsible Party):
Da Volterra
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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.
| Condition or disease |
|---|
| Intestinal Bacteria Flora Disturbance |
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 Type : | Observational |
| Actual Enrollment : | 272 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 Start Date : | March 2012 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | December 2013 |
| Group/Cohort |
|---|
| lifestyle condition |
Primary Outcome Measures :
- Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France [ Time Frame: 12 months ]
Secondary Outcome Measures :
- Quantitative measurement of MDRGNB in fecal samples (expressed as log10 and percentage) of volunteers after staying 4-6 months outside France [ Time Frame: 12 months ]
- Quantitative variation of MDRGNB between the departure and return in volunteers [ Time Frame: 12 months ]
- PCR and sequencing of resistance genes from strains of interest [ Time Frame: 12 months ]
- Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France [ Time Frame: 12 months ]
Biospecimen Retention: Samples Without DNA
Stool
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Volunteers from French Armed Forces
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591538
Locations
| France | |
| Centre d'épidémiologie et de santé publique des armées | |
| Saint Mandé cedex, France, 94163 | |
Sponsors and Collaborators
Da Volterra
Investigators
| Principal Investigator: | Jean-Baptiste MEYNARD, MD/PhD | French Armed Forces |
| Responsible Party: | Da Volterra |
| ClinicalTrials.gov Identifier: | NCT01591538 History of Changes |
| Other Study ID Numbers: |
DAV148-EPI-01 ID RCB number : 2011-A01569-32 ( Other Identifier: AFSSAPS ) |
| First Posted: | May 4, 2012 Key Record Dates |
| Last Update Posted: | May 29, 2014 |
| Last Verified: | May 2014 |
Keywords provided by Da Volterra:
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Prevalence MDRGNB Acquisition Middle stay Endemic area |
Additional relevant MeSH terms:
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Dysbiosis Pathologic Processes |