Evaluation of the Effectiveness of a Diagnostic Kit in the Etiological Diagnosis of Fevers of the Traveler
Primary Purpose
Fevers of the Traveler
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Fevers of the Traveler
Eligibility Criteria
Inclusion Criteria:
- Patient with a T >38.5 ° C with or without associated clinical signs.
- Patient who traveled outside metropolitan France within 45 days with the hospitalization.
- Patient is more than 18 years old.
- Patient who accept to have his medical records reviewed for research.
- Patient with health insurance
Exclusion Criteria:
- a feverish syndrome beyond 45 days after the return of their journey.
- a clinical symptomatologie on the return to journey without associated fever,
- minor(miner) ( 18 years).
- Pregnant or breast-feeding woman.
- Incapable major patient or outside state to express its consent.
Sites / Locations
- Asssitance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fevers of the travelers
Arm Description
Outcomes
Primary Outcome Measures
Number of etiological diagnosis established in relation to the number of prescribed kits
Secondary Outcome Measures
Full Information
NCT ID
NCT02827175
First Posted
July 6, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02827175
Brief Title
Evaluation of the Effectiveness of a Diagnostic Kit in the Etiological Diagnosis of Fevers of the Traveler
Official Title
Evaluation of the Effectiveness of a Diagnostic Kit in the Etiological Diagnosis of Fevers of the Traveler
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2014 (Actual)
Primary Completion Date
July 24, 2019 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Annually about 10 to 15 million international travelers from Europe visit tropical countries. Returning from a journey, fever is the cardinal symptom of many infections. This is the second reason for consultation (23%) for return from a trip, after digestive disorders (42%). Urgent evaluation must always be proposed. Although that may be the manifestation of a benign disease, fever of return can also presage a rapidly progressive and lethal disease. In 50% of cases, patients return home, after treatment and disappearance of symptoms, though the microorganism responsible for the pathology is not able to be identified. The prescription of a series of systematic biological examinations in the form of a diagnostic kit has shown its relevance and its effectiveness in improving the etiological diagnosis of endocarditis and pericardites for optimal support. In this study we propose to assess the effectiveness of the systematic prescription of a diagnostic kit 'fever of the traveler' to all patients hospitalized with a fever after returning from a trip. "Ready to use" kit brings together in a single bag (i) instructions for use, (ii) the tubes, bottles and jars for the etiological diagnosis of fever of the traveler in the usual support (iii) an additional blood tube for research of pathogens emerging.
Primary:
To assess the effectiveness of a diagnostic kit for the etiological diagnosis of fevers of travelers on the return.
Hypothesis:
Improvement of at least 15% of the etiological diagnosis of fevers of travelers on the return through the development of a diagnostic kit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fevers of the Traveler
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fevers of the travelers
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
blood sample
Primary Outcome Measure Information:
Title
Number of etiological diagnosis established in relation to the number of prescribed kits
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with a T >38.5 ° C with or without associated clinical signs.
Patient who traveled outside metropolitan France within 45 days with the hospitalization.
Patient is more than 18 years old.
Patient who accept to have his medical records reviewed for research.
Patient with health insurance
Exclusion Criteria:
a feverish syndrome beyond 45 days after the return of their journey.
a clinical symptomatologie on the return to journey without associated fever,
minor(miner) ( 18 years).
Pregnant or breast-feeding woman.
Incapable major patient or outside state to express its consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
catherine GEINDRE
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Asssitance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the Effectiveness of a Diagnostic Kit in the Etiological Diagnosis of Fevers of the Traveler
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