Multi-Antibiotic Resistance Carriage in Gut Flora (MARC)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|
|
Intestinal Bacteria Flora Disturbance |
| Study Type: | Observational |
| Study Design: | 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 |
- Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Quantitative variation of MDRGNB between the departure and return in volunteers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- PCR and sequencing of resistance genes from strains of interest [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Stool
| Estimated Enrollment: | 272 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| lifestyle condition |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Volunteers from French Armed Forces
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.
Contacts and Locations| Contact: Annie DUCHER, MD | +33 1 1 58 39 32 20 | annie.ducher@davolterra.com |
| France | |
| Centre d'épidémiologie et de santé publique des armées | Recruiting |
| Saint Mandé cedex, France, 94163 | |
| Contact: Jean Baptiste MEYNARD +33 1 43 98 50 70 jb.meynard@wanadoo.fr | |
| Principal Investigator: | Jean-Baptiste MEYNARD, MD/PhD | French Armed Forces |
More Information
No publications provided
| Responsible Party: | Da Volterra |
| ClinicalTrials.gov Identifier: | NCT01591538 History of Changes |
| Other Study ID Numbers: | DAV148-EPI-01, ID RCB number : 2011-A01569-32 |
| Study First Received: | May 2, 2012 |
| Last Updated: | May 3, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Da Volterra:
|
Prevalence MDRGNB Acquisition Middle stay Endemic area |
ClinicalTrials.gov processed this record on May 23, 2013