Etiological Diagnosis of Traveler's Diarrhoea

NCT ID: NCT02866201

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-15
• Study Completion Date: 2022-10-26

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%.

Conditions

Traveler's Diarrhoea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient suffering from traveler's diarrhoea

Patient suffering form traveler's diarrhoea during a stay (up to 3 months) outside metropolitan France

Group Type: EXPERIMENTAL

Rectal swab

Intervention Type: OTHER

Interventions

Rectal swab

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine GEINDRE

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2012-48

Identifier Type: -

Identifier Source: org_study_id