Etiological Diagnosis of Traveler's Diarrhoea

NCT02866201 | Completed

• 1 other identifier: 2012-48
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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

Keywords

Turista

Outcome Measures

Primary Outcomes (1)

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

  Up to 6 months

Study Arms (1)

Patient suffering from traveler's diarrhoea

EXPERIMENTAL

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

Other: Rectal swab

Interventions

Rectal swab OTHER

Patient suffering from traveler's diarrhoea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

• Catherine GEINDRE

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 15, 2016
• Study Start: September 15, 2013
• Primary Completion: February 8, 2019
• Study Completion: October 26, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

FR (1)