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Etiological Diagnosis of Traveler's Diarrhoea (DIAVOY)

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ClinicalTrials.gov Identifier: NCT02866201
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
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%.


Condition or disease Intervention/treatment Phase
Traveler's Diarrhoea Other: Rectal swab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : August 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Patient suffering from traveler's diarrhoea
Patient suffering form traveler's diarrhoea during a stay (up to 3 months) outside metropolitan France
Other: Rectal swab



Primary Outcome Measures :
  1. Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866201


Contacts
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Contact: Philippe GAUTRET 04 91 96 89 35 ext +33 philippe.gautret@ap-hm.fr
Contact: Alexandra GIULIANI 04 91 38 28 70 ext +33 alexandra.giuliani@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: philippe BROUQUI         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Catherine GEINDRE Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02866201     History of Changes
Other Study ID Numbers: 2012-48
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique Hopitaux De Marseille:
Turista

Additional relevant MeSH terms:
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Dysentery
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases