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Completed

NCT Number: NCT01591538

Multi-Antibiotic Resistance Carriage in Gut Flora

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.

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Key information

Conditions

Intestinal Bacteria Flora Disturbance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre d'épidémiologie et de santé publique des armées

Saint-Mandé, 94163, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France

    Time frame: 12 months

Secondary outcomes

  1. 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

  2. Quantitative variation of MDRGNB between the departure and return in volunteers

    Time frame: 12 months

  3. PCR and sequencing of resistance genes from strains of interest

    Time frame: 12 months

  4. Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Da Volterra

Industry

Registry information

Official study 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

Acronym: MARC

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 4, 2012
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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