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临床试验/NCT01676974
NCT01676974已完成不适用

Impact of International Travel on the Emergence and Spread of Antimicrobial Resistance in The Netherlands

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)3 个研究点 分布在 1 个国家目标入组 2,215 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,215
试验地点
3
主要终点
acquisition rate

研究概览

简要总结

Objectives: Prospectively study the influence of foreign travel and associated risk factors on the acquisition of AMR in the endogenous microbiota of healthy individuals and the subsequent persistence of AMR carriage and transmission to household members of these carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of bacterial infections in the year after travel (compared to non-carriers). Explore the full width of AMR genes and transferable genetic elements acquired during international travel.

详细描述

Rationale: Antimicrobial resistance (AMR) among Enterobacteriaceae constitutes an increasingly important human health hazard worldwide. Also in the Netherlands AMR rates have been on the rise in recent years. A limited number of previous studies have suggested high acquisition rates of AMR E. coli during international travel, but information on travel-associated risk factors, duration of colonization and local transmission of imported AMR are largely, if not entirely, lacking.

Objectives: Prospectively study the influence of foreign travel and associated risk factors on the acquisition of AMR in the endogenous microbiota of healthy individuals and the subsequent persistence of AMR carriage and transmission to household members of these carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of bacterial infections in the year after travel (compared to non-carriers). Explore the full width of AMR genes and transferable genetic elements acquired during international travel.

Study design: multicenter longitudinal cohort study.

Study population: healthy, adult (> 18 years) volunteers travelling abroad for 1 week - 3 months. Non travelling household members of these traveling volunteers.

Methods: Travelers and non-traveling household members will be recruited at outpatient travel clinics throughout The Netherlands. Faecal samples and questionnaires will be taken before (t=0) travel, immediately after travel (t=1) and 1 month upon return (t = 2). For volunteers that acquire AMR Enterobacteriaceae, repeated questionnaires and faecal samples will be taken after 3, 6 and 12 months.

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

入选标准

  • age > 18 years
  • travelling for > 1 week (7 days) AND < 3 months (90 days)
  • non traveling household members of these traveling volunteers

排除标准

  • 未提供

结局指标

主要结局

acquisition rate

时间窗: 1 year

the acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel

次要结局

  • identification of risk factors(1 year)
  • duration of colonization(1 year)
  • occurrence of self-reported infections in the year following travel(1 year)
  • rate of secondary transmission within households(1 year)
  • abundance and type of resistance(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Menno D. de Jong, MD

Prof. dr. M.D. de Jong

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (3)

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