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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

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date August 15, 2016
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea [ Time Frame: Up to 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Etiological Diagnosis of Traveler's Diarrhoea
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Traveler's Diarrhoea
Intervention  ICMJE Other: Rectal swab
Study Arms  ICMJE Experimental: Patient suffering from traveler's diarrhoea
Patient suffering form traveler's diarrhoea during a stay (up to 3 months) outside metropolitan France
Intervention: Other: Rectal swab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
7500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02866201
Other Study ID Numbers  ICMJE 2012-48
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Catherine GEINDRE Assistance Publique Hôpitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP