Etiological Diagnosis of Traveler's Diarrhoea (DIAVOY)
Primary Purpose
Traveler's Diarrhoea
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rectal swab
Sponsored by
About this trial
This is an interventional diagnostic trial for Traveler's Diarrhoea focused on measuring Turista
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient suffering from traveler's diarrhoea
Arm Description
Patient suffering form traveler's diarrhoea during a stay (up to 3 months) outside metropolitan France
Outcomes
Primary Outcome Measures
Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea
Secondary Outcome Measures
Full Information
NCT ID
NCT02866201
First Posted
August 10, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02866201
Brief Title
Etiological Diagnosis of Traveler's Diarrhoea
Acronym
DIAVOY
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2013 (Actual)
Primary Completion Date
February 8, 2019 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traveler's Diarrhoea
Keywords
Turista
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient suffering from traveler's diarrhoea
Arm Type
Experimental
Arm Description
Patient suffering form traveler's diarrhoea during a stay (up to 3 months) outside metropolitan France
Intervention Type
Other
Intervention Name(s)
Rectal swab
Primary Outcome Measure Information:
Title
Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine GEINDRE
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Etiological Diagnosis of Traveler's Diarrhoea
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