International Travel and the Spread of Extended-spectrum Beta-lactamase-producing Escherichia Coli

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Calgary.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT01296165
First received: February 14, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

It is not clear why multi-resistant E. coli (also known as ESBL-producing) have recently became such important causes of infections in patients living and residing in the community. A risk factor analysis study performed during 2004 and 2005 in Calgary had shown that the consumption of the same types of food or well water sources were not significant risk factors for community-associated infections due to these E. coli. However, a significant and unexpected risk factor among these Calgary patients was recent visits to certain high-risk areas such as the Indian subcontinent (India, Pakistan), Africa and the Middle East. Therefore it is possible that international travel to certain high-risk destinations might play, in part, a role in the spread of multi-resistant E. coli across different continents. This would happen via the acquisition of these bacteria in the rectums of returning travelers and the same organism would later cause an infection. However, the evidence that the spread and infections due to ESBL-producing E. coli are associated with international travel is circumstantial at best and the investigators would like to prove that this is indeed true.

The basic idea of the study is to culture the stool of travelers for ESBL-producing E. coli before they leave for India, within seven days after their return to Canada and again after six months. The investigators can then establish which travelers are rectally colonized when visiting India and if these bacteria are still present six months after their return. A detailed questionnaire regarding the traveler's itinerary and behaviours in India will be completed on their return to Canada. The investigators will then compare the itinerary and behaviours of colonized travelers with those of non-colonized travelers and identify certain high-risk behaviours and places for acquiring ESBL-producing E. coli in India. The investigators will also determine if colonized travelers will later develop infections with the same ESBL-producing E. coli they acquired while visiting India.


Condition Intervention
Infection Due to Resistant Bacteria
Behavioral: Analysing the behaviours of travellers while visiting India

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Importance of International Travel in the Spread of Extended-spectrum Beta-lactamase-producing Escherichia Coli

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • To determine the rate of rectal acquisition of ESBL-producing E. coli in travelers to India (i.e. risk of becoming colonized). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Travelers who agree to participate will have a detailed travel itinerary and a stool specimen collected prior to travel. Study participants will be requested to return to the travel clinics within 7 days after their return to Canada and a following-up stool specimen will be obtained at the second visit. The specimens will consist of stool and not rectal swabs. The stool specimens in a transport medium will be submitted to Calgary Laboratory Services and frozen at -20°C for further analyses. The proportion of travelers who become positive for ESBL-producing E. coli will be determined.


Secondary Outcome Measures:
  • To identify the different behaviours of travelers in the India that put them at a high risk for acquiring ESBL-producing E. coli (i.e. risk factors of becoming colonized). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Study participants will be requested to return to the travel clinics within 7 days after their return to Canada and complete a detailed questionnaire regarding their itinerary and behaviours during the visit. The completed questionnaire will be forwarded to the Pitout's laboratory and entered into a central database for further analysis.


Biospecimen Retention:   Samples With DNA

Stool specimens


Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Travellers visiting India
People that are older than 18 years and planning to visit India for a period of at least 5 days will be approached by the personal at the travel clinics to participate in the study. Informed consent will be obtained prior to enrolling subjects.
Behavioral: Analysing the behaviours of travellers while visiting India
For analyses surrounding the risks for acquisition comparisons between those who acquire ESBLs and those who do not, will be made using Stata version 9.0 (Stata Corp, College Station, TX). Differences in proportions among categorical data will be assessed using Fisher's exact test for pair-wise comparisons. Student T-test or Mann-Whitney U tests will be used for comparing means and medians. For all statistical comparisons a p-value <0.05 will be deemed to represent statistical significance.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Travelers older than 18 years old that will visit India for longer than 5 days.

Criteria

Inclusion Criteria:

  • People that are older than 18 years old
  • Planning to visit India for a period of at least 5 days

Exclusion Criteria:

  • If a traveler tests positive for ESBL-producing E. coli before leaving for India
  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: NCT01296165

Contacts
Contact: Johann Pitout, MD (403) 770 3309 johann.pitout@cls.ab.ca

Locations
Canada, Alberta
Odessa Travel clinic Not yet recruiting
Calgary, Alberta, Canada, T2L2K8
Contact: Susan Susan Kuhn, MD    (403) 955-7813    susan.kuhn@albertahealthservices.ca   
Sub-Investigator: Susan Kuhn, MD         
Sponsors and Collaborators
University of Calgary
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Johann Pitout, MD University of Calgary
  More Information

Publications:
Responsible Party: Johann DD Pitout, University of Calgary
ClinicalTrials.gov Identifier: NCT01296165     History of Changes
Other Study ID Numbers: 38027
Study First Received: February 14, 2011
Last Updated: February 14, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Travel
Spread
Antibiotic resistance

ClinicalTrials.gov processed this record on October 21, 2014