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
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
- 是
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
Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received standard pre-travel advice
Intervention Group
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
Christoph Hatz
Prof. Dr. med. Christoph Hatz
Swiss Tropical & Public Health Institute
