- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02866201
Etiological Diagnosis of Traveler's Diarrhoea (DIAVOY)
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%.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient suffering from traveler's diarrhoea
Patient suffering form traveler's diarrhoea during a stay (up to 3 months) outside metropolitan France
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea
Time Frame: Up to 6 months
|
Up to 6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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