Rapid Flu Tests in Travelers With Fever
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
BD Directigen EZ Flu A+B
Control
Sponsored by
About this trial
This is an interventional diagnostic trial for Influenza focused on measuring Influenza, Rapid flu test, Returning travelers with fever
Eligibility Criteria
Inclusion Criteria:
- Adults 18 years or older
- Returning from abroad within the last 14 days
- Documented fever of 38oC or above or anamnestic fever + cough or sore throat within the last 4 days before the consultation.
Exclusion Criteria:
- Unwillingness to participate
Sites / Locations
- Tropical Institute Basel
- Medical outpatient clinic, University Hospital of Lausanne
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Rapid test
Comparator
Arm Description
Returning travelers with fever will have a rapid flu test
Returning travelers with fever will benefit of the usual medical care, without rapid flu test
Outcomes
Primary Outcome Measures
Cost for the Medical Management of Patients
Secondary Outcome Measures
Chest X-ray Requested
Number of patients for whom a chest X-ray was requested as part of the medical management
Number of Patients Receiving a Prescription for Antibiotics
Full Information
NCT ID
NCT00821626
First Posted
January 12, 2009
Last Updated
March 23, 2020
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT00821626
Brief Title
Rapid Flu Tests in Travelers With Fever
Official Title
Utility of Rapid Flu Tests in the Medical Management of Returning Travelers With Fever
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Influenza is a frequent cause of fever in returning travelers. Usually diagnosis rests on the clinical picture. Rapid flu tests are becoming increasingly popular, although their sensitivity and specificity are suboptimal. The objective of this study is to evaluate if rapid flu tests influence the medical management of returning travelers with fever, a population at intermediate risk for influenza infections.
Detailed Description
Travelers are at risk of acquiring infectious diseases. Previous studies have estimated that about 11% of travelers develop fever during or shortly after their trip abroad. Influenza has been shown to be one of the most important cause of fever amongst travelers. A sero-epidemiological survey showed that 27 of 211 patients (12.8%) with fever during or after a trip abroad developed antibodies against the influenza virus. Another study showed that 13% of travellers, who consulted after return with flu-like symptoms, had PCR or culture-proven influenza. The incidence of influenza in travellers varies according to the seasons, but cases can be seen year round. In tropical countries transmission is year-long and in the southern hemisphere the flu epidemics occur during the summer of the northern hemisphere.
In most hospitals no confirmatory test for influenza is routinely done. For special cases a PCR or viral culture can be requested, but the results are only available after 48 hours for the PCR and after several days for the culture. It is suspected that the inability to confirm the diagnosis of flu contributes to the request of a greater number of useless investigations and inappropriate use of anti-infective treatments.
Rapid diagnostic tests are easy to use, relatively cheap and they yield a result within a clinically relevant time frame (30 minutes). For the detection of influenza there are a variety of rapid diagnostic tests on the market. The reported sensitivities and specificities are quite variable, but the new generations report median sensitivities of 70 - 75% and median specificities between 90 and 95%. The rapid tests are considered most useful in patient populations with a significant proportion of influenza cases. The WHO encourages to use rapid diagnostic tests for influenza in returning travelers with fever, considering that this patient population is at significant risk of acquiring influenza during their trip.
The aim of this study is to evaluate if rapid flu tests influence the medical management of returning travelers with fever
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Rapid flu test, Returning travelers with fever
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid test
Arm Type
Active Comparator
Arm Description
Returning travelers with fever will have a rapid flu test
Arm Title
Comparator
Arm Type
Sham Comparator
Arm Description
Returning travelers with fever will benefit of the usual medical care, without rapid flu test
Intervention Type
Device
Intervention Name(s)
BD Directigen EZ Flu A+B
Other Intervention Name(s)
BD Directigen EZ Flu A+B, serial number 8010589
Intervention Description
Naso-pharyngeal swab and rapid flu test
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No rapid flu test
Primary Outcome Measure Information:
Title
Cost for the Medical Management of Patients
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Chest X-ray Requested
Description
Number of patients for whom a chest X-ray was requested as part of the medical management
Time Frame
4 years
Title
Number of Patients Receiving a Prescription for Antibiotics
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults 18 years or older
Returning from abroad within the last 14 days
Documented fever of 38oC or above or anamnestic fever + cough or sore throat within the last 4 days before the consultation.
Exclusion Criteria:
Unwillingness to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge de Valliere, MD
Organizational Affiliation
Medical Outpatient Clinic, University Hospital of Lausanne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tropical Institute Basel
City
Basel
ZIP/Postal Code
4002
Country
Switzerland
Facility Name
Medical outpatient clinic, University Hospital of Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
26358968
Citation
Berthod D, Genton B, Hatz C, Blum J, de Valliere S. Ability of physicians to diagnose influenza and usefulness of a rapid influenza antigen test in febrile returning travelers: A randomized controlled trial. Travel Med Infect Dis. 2015 Sep-Oct;13(5):394-9. doi: 10.1016/j.tmaid.2015.08.001. Epub 2015 Aug 28.
Results Reference
derived
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Rapid Flu Tests in Travelers With Fever
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