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临床试验/NCT02866201
NCT02866201已完成不适用

Etiological Diagnosis of Traveler's Diarrhoea

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2013年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
226
试验地点
2
主要终点
Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea

研究概览

简要总结

Traveler's diarrhoea or turista is the most common disease in travelers. It has been reported based on studies in 20 to 60% of travelers, depending among other conditions and travel destinations. Currently, less than 30% of the etiology of diarrhoea is identified by bacteriological v,irological and parasitology traditional techniques. This ignorance of the diarrhoea etiology causes difficulties in the establishment of a specific and rapid management in this extremely common condition and having a significant cost to society. Technological advances in laboratory diagnosis, such as quantitative real-time Polymerase Chain Reaction (PCR), can allow us now to improve the etiological diagnosis of traveler's diarrhoea using simple rectal swabs.

So, the principal objective of this study is to assess the efficacy of a new diagnosis strategy in order to establissh the etiological diagnosis of traveler's diarrhoea. The hypothesis consists in improving the number of patients with a confirmed etiological diagnosis of traveler's diarrhoea by 5%.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Patient leaving for a trip outside France for a period (not exceeding 3 months)
  • Patient who get seen by Travel information Service at hospital before departure.
  • Adult patients (> 18 years).
  • Patient who freely signed the written informed consent
  • Patient affiliated to a social security regime. Exclusion criteria
  • Minor patient (<18 years)
  • Pregnant or nursing woman.
  • Adult patient under guardianship.
  • Patient deprivated with liberty under court order.
  • Patient refusing to sign the wrtten consent form

排除标准

  • 未提供

结局指标

主要结局

Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea

时间窗: Up to 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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