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临床试验/NCT03306407
NCT03306407已完成不适用

A Multicentre Intervention Study on the Use of Hand Sanitizers in the Prevention of Intestinal Colonization With Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Travellers to the Indian Subcontinent

Christoph Hatz4 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2015年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
290
试验地点
4
主要终点
Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia

研究概览

简要总结

Travelling to tropical and subtropical countries is a known risk factor for becoming colonized with extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae. Especially travellers returning from the Indian subcontinent show high colonization rates of up to almost 90%.

While risk factors for becoming colonized have been identified in several studies, no preventive measure has been tested so far.

One of the factors associated with becoming colonized while travelling is suffering from travellers' diarrhoea. Earlier studies looking at diarrhoea in childhood as well as school and/or work absenteeism because of diarrhoeal diseases have shown protective effects through good hand hygiene. Furthermore, a recent retrospective study has shown lower rates of travellers' diarrhoea in people using hand gel sanitizers. Improving hand hygiene in travellers through increased hand washing and the use of hand gel sanitizers might therefore not only decrease the rate of travellers' diarrhoea but the carriage rate with ESBL-producing Enterobacteriaceae as well. However, there is no prospective data available to prove the usefulness of such an intervention, neither in the prevention of travellers' diarrhoea nor in the prevention of colonization.

In the current study, investigators plan to compare colonization rates with ESBL-producing Enterobacteriaceae in travellers receiving pre-travel advice on improved hand hygiene (including the use of hand gel sanitizers) with travelers receiving standard advice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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 to the Indian subcontinent (India, Bhutan and/or Nepal) for up to 4 weeks

排除标准

  • age < 18 years
  • travelling to other destinations than India, Bhutan and/or Nepal
  • antibiotic treatment at the time of the first sampling

研究组 & 干预措施

Baseline Group

No Intervention

Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received standard pre-travel advice

Intervention Group

Active Comparator

Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received pre-travel advice with special focus on improved hand hygiene including the use of hand gel sanitizer (Hartmann Sterillium) (bundle intervention)

干预措施: Improved hand hygiene (Other)

结局指标

主要结局

Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia

时间窗: up to 1 week after travel

Coloinzation rates with ESBL-producing Enterobacteriaceae in travellers

次要结局

  • Incidence of travellers' diarrhoea (during and up to 2 weeks after travelling, assessed through self-reporting)(up to 2 weeks after travel)

研究者

发起方
Christoph Hatz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christoph Hatz

Prof. Dr. med. Christoph Hatz

Swiss Tropical & Public Health Institute

研究点 (4)

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