The Importance of International Travel in the Spread of Extended-spectrum Beta-lactamase-producing Escherichia Coli
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- To determine the rate of rectal acquisition of ESBL-producing E. coli in travelers to India (i.e. risk of becoming colonized).
研究概览
简要总结
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.
详细描述
Title The importance of international travel in the spread of extended-spectrum beta-lactamase-producing Escherichia coli.
Principal investigator Johann DD Pitout, Professor, University of Calgary, Department of Pathology and Laboratory Medicine, no 9, 3535 Research Road NW, Calgary, Alberta, Canada, T2L 2K8. Tel: (403) 770 3338. Fax: (403) 770 3347. johann.pitout@cls.ab.ca
Background and rationale: The changing epidemiology of infections caused by extended-spectrum beta-lactamases-producing bacteria Since 2000 Escherichia coli producing CTX-M enzymes have emerged worldwide as important causes of community-onset urinary tract (UTIs) and blood stream infections due to extended-spectrum beta-lactamase (ESBL)-producing bacteria. Studies from different continents suggested that the sudden worldwide increase of CTX-M-producing E. coli is often due to the emergence of a clone named ST131. It also seems that foreign travel to high-risk areas such as the Indian subcontinent (India, Pakistan) might play, in part, a role in the spread of CTX-M-producing E. coli across different continents. However, the evidence that infections due to ESBL-producing E. coli are associated with international travel is circumstantial and the investigators would like to prove that this is indeed true.
Hypothesis:
Our primary hypothesis is that when travelers visit India, they have a risk of acquiring CTX-M-producing E. coli in their rectums (i.e. there is high risk of rectal colonization with these bacteria). The reason for selecting India is that a previous study from Calgary had shown that the risk for post-travel infections is the highest for travelers returning from this country. The investigators also believe the acquisition of these bacteria is associated with certain high-risk behaviors during travel in India such as drinking water from wells, consuming certain food products or taking antibiotics. Our secondary hypothesis is that some travelers that are colonized with CTX-M-producing E. coli on their return from India, will later develop infections (most likely UITs) with the same bacteria that were first present in their rectums.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People that are older than 18 years old
- •Planning to visit India for a period of at least 5 days
排除标准
- •If a traveler tests positive for ESBL-producing E. coli before leaving for India
结局指标
主要结局
To determine the rate of rectal acquisition of ESBL-producing E. coli in travelers to India (i.e. risk of becoming colonized).
时间窗: 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.
次要结局
- 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)
研究者
Johann DD Pitout
Dr
University of Calgary