Travel in the Tropics and Acquisition of Multidrug-resistant Bacteria (VOYAG-R)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01526187
First received: February 1, 2012
Last updated: December 31, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to Measure the fecal carriage of multidrug-resistant bacteria after a travel in the tropics.


Condition
Fecal Carriage of Multidrug-resistant Bacteria

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acquisition of Multidrug-resistant Bacteria After Travel in the Tropics : Prevalence, Determinants and Length of Carriage

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The primary endpoint is defined by the presence of MRE in the stool back from traveling in the tropics in patients who were not carriers before travel. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Location, acquisition of data regarding travel conditions and traveller's profile [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    1. - Location: Asia, Sub-Saharan Africa, Latin America
    2. - Acquisition of data: sex, age, socioeconomic status, diet, frequency of history of travel in the same geographical area, type of antimalarial prophylaxis (and compliance), type of stay, occurrence


Biospecimen Retention:   Samples Without DNA

Stool


Estimated Enrollment: 750
Study Start Date: February 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sub-Saharan Africa
Asia
Latin America

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult volunteers in the vaccination center prior to a travel in the tropics.

Criteria

Inclusion Criteria:

  • Age greater than 18 years
  • Consulting a vaccination center
  • Travel in the tropics for a minimum of 2 days and maximum of 90 day

Exclusion Criteria:

  • Pregnant woman (known pregnancy) or breastfeeding
  • Refusal to participate in the study,
  • Accompanied by a subject already included,
  • Subject has already been included in the study,
  • Inability to follow in the weeks following the return trip in the tropics.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526187

Locations
France
Hôpital BICHAT - CLAUDE BERNARD
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Sophie MATHERON, MD,PHD APHP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01526187     History of Changes
Other Study ID Numbers: NI 11012 (AOR 11101)
Study First Received: February 1, 2012
Last Updated: December 31, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Public Health and Epidemiology
Bacteriology
Infectious and Tropical

ClinicalTrials.gov processed this record on September 30, 2014