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

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.

Study Overview

• Status: Completed
• Conditions: Fevers of the Traveler
• Intervention / Treatment: Other: blood sample

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: philippe BROUQUI; Email: philippe.brouqui@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Asssitance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fevers of the travelers	Other: blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of etiological diagnosis established in relation to the number of prescribed kits	3 years

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2014
• Primary Completion (Actual): July 24, 2019
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Fever
• Other Study ID Numbers: 2013-45; 2013-A01536-39 (Other Identifier: idrcb)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED