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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: March 27, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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
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: March 27, 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 May 22, 2013