Etiological Diagnosis of Traveler's Diarrhoea

Traveler's Diarrhoea Clinical Trial

— DIAVOY  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866201
• Other study ID #: 2012-48
• Status: Completed
• Phase: N/A
• Start date: September 15, 2013
• Est. completion date: October 26, 2022

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: October 26, 2022
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Dysentery
• Traveler's Diarrhoea

Intervention

Other:
• Rectal swab

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea		Up to 6 months