Etiological Diagnosis of Traveler's Diarrhoea

Not Applicable

Completed

• Conditions: Traveler's Diarrhoea
• Interventions: Other: Rectal swab

• Registration Number: NCT02866201
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-15
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Primary Completion: 2019-02-08
• Study Completion: 2022-10-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient suffering from traveler's diarrhoea	Rectal swab	Patient suffering form traveler's diarrhoea during a stay (up to 3 months) outside metropolitan France

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea	Up to 6 months

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France