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CompletedNCT02827175Updated Apr 21, 2023

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

An interventional study of blood sample in Fevers of the Traveler, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jan 2014, registered Jul 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Fevers of the Traveler

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03

In context

Fever

602 studies on the registry are indexed under Fever; 102 are open to participants now.

This study's enrollment of 110 is close to the median of 100 across 382 interventional studies indexed under Fever.

Browse Fever studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    fevers of the travelers

    Other: blood sample

Interventions

  • Otherblood sample
06

What researchers measure

Primary outcomes

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

    Time frame: 3 years

07

Study locations

1 site
  • Asssitance Publique Hopitaux de Marseille
    Marseille, 13354, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02827175
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jul 11, 2016
Start date
Jan 7, 2014
Primary completion
Jul 24, 2019
Completion
Oct 26, 2022
Last update
Apr 21, 2023

Study contacts

catherine GEINDRE
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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