International Travel and the Spread of Extended-spectrum Beta-lactamase-producing Escherichia Coli
|ClinicalTrials.gov Identifier: NCT01296165|
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : December 3, 2014
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 or disease||Intervention/treatment|
|Infection Due to Resistant Bacteria||Behavioral: Analysing the behaviours of travellers while visiting India|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||173 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||The Importance of International Travel in the Spread of Extended-spectrum Beta-lactamase-producing Escherichia Coli|
|Study Start Date :||July 2011|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
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.
- 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 ]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.
- 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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296165
|Odessa Travel clinic|
|Calgary, Alberta, Canada, T2L2K8|
|Principal Investigator:||Johann Pitout, MD||University of Calgary|