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

NCT01296165 | Completed DMC

• 1 other identifier: 38027
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection Due to Resistant Bacteria

Keywords

Travel; Spread; Antibiotic resistance

Outcome Measures

Primary Outcomes (1)

• To determine the rate of rectal acquisition of ESBL-producing E. coli in travelers to India (i.e. risk of becoming colonized).

  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.

  24 months

Secondary Outcomes (1)

• 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).

  24 months

Study Arms (1)

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

Interventions

Analysing the behaviours of travellers while visiting India BEHAVIORAL

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.

Travellers visiting India

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johann DD Pitout: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Odessa Travel clinic

Calgary, Alberta, T2L2K8, Canada

Location

Related Publications (2)

• Pitout JD, Campbell L, Church DL, Gregson DB, Laupland KB. Molecular characteristics of travel-related extended-spectrum-beta-lactamase-producing Escherichia coli isolates from the Calgary Health Region. Antimicrob Agents Chemother. 2009 Jun;53(6):2539-43. doi: 10.1128/AAC.00061-09. Epub 2009 Apr 13.

  PMID: 19364876 BACKGROUND

• Peirano G, Gregson DB, Kuhn S, Vanderkooi OG, Nobrega DB, Pitout JDD. Rates of colonization with extended-spectrum beta-lactamase-producing Escherichia coli in Canadian travellers returning from South Asia: a cross-sectional assessment. CMAJ Open. 2017 Dec 13;5(4):E850-E855. doi: 10.9778/cmajo.20170041. Epub 2017 Dec 15.

  PMID: 29246886 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool specimens

Study Officials

• Johann Pitout, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

CA (1)