Evaluation of the Effectiveness of a Diagnostic Kit in the Etiological Diagnosis of Fevers of the Traveler

NCT02827175 | Completed

• 2 other identifiers: 2013-452013-A01536-39
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Fevers of the Traveler

Outcome Measures

Primary Outcomes (1)

• Number of etiological diagnosis established in relation to the number of prescribed kits

  3 years

Study Arms (1)

fevers of the travelers

EXPERIMENTAL

Other: blood sample

Interventions

blood sample OTHER

fevers of the travelers

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Asssitance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• catherine GEINDRE

  Assistance Publique Hopitaux 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: July 6, 2016
• First Posted: July 11, 2016
• Study Start: January 7, 2014
• Primary Completion: July 24, 2019
• Study Completion: October 26, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

FR (1)