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Improving the Diagnosis of Traveller's Fevers in Point Of Care (POC)

Primary Purpose

Traveller's Fever

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rectal Swab
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Traveller's Fever

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient admitted for traveller's fever requiring a microbiological examination with a "Traveller's fever POC kit"
  • Patient who freely signed the informed consent form
  • Patient affiliated to a social security regime

Exclusion criteria

  • Pregnant or breastfeeding women
  • Adult patient under guardianship
  • Patient deprived with liberty under court order
  • Patient refusing or unable to sign the informed consent form

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients admitted for traveller's fever

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients admitted for traveller's fever with a confirmed etiological diagnosis

Secondary Outcome Measures

Full Information

First Posted
August 11, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02868411
Brief Title
Improving the Diagnosis of Traveller's Fevers in Point Of Care (POC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 11, 2013 (Actual)
Primary Completion Date
February 8, 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
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of traveller's fever caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC traveller's fever tests . The objective of this study is to implement a new diagnosis strategy relying on the hypothesis that a rectal swab would improve the etiological diagnosis of traveller's fever of at least 10%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traveller's Fever

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients admitted for traveller's fever
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Rectal Swab
Primary Outcome Measure Information:
Title
Percentage of patients admitted for traveller's fever with a confirmed etiological diagnosis
Time Frame
1 day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient admitted for traveller's fever requiring a microbiological examination with a "Traveller's fever POC kit" Patient who freely signed the informed consent form Patient affiliated to a social security regime Exclusion criteria Pregnant or breastfeeding women Adult patient under guardianship Patient deprived with liberty under court order Patient refusing or unable to sign the informed consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine GEINDRE
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Improving the Diagnosis of Traveller's Fevers in Point Of Care (POC)

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