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Rapid Flu Tests in Travelers With Fever

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00821626
Recruitment Status : Completed
First Posted : January 13, 2009
Results First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Information provided by (Responsible Party):
Serge de Valliere, University of Lausanne Hospitals

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.

Condition or disease Intervention/treatment Phase
Influenza Device: BD Directigen EZ Flu A+B Other: Control Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Utility of Rapid Flu Tests in the Medical Management of Returning Travelers With Fever
Study Start Date : January 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Rapid test
Returning travelers with fever will have a rapid flu test
Device: BD Directigen EZ Flu A+B
Naso-pharyngeal swab and rapid flu test
Other Name: BD Directigen EZ Flu A+B, serial number 8010589

Sham Comparator: Comparator
Returning travelers with fever will benefit of the usual medical care, without rapid flu test
Other: Control
No rapid flu test

Primary Outcome Measures :
  1. Cost for the Medical Management of Patients [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Chest X-ray Requested [ Time Frame: 4 years ]
    Number of patients for whom a chest X-ray was requested as part of the medical management

  2. Number of Patients Receiving a Prescription for Antibiotics [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00821626

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Tropical Institute Basel
Basel, Switzerland, 4002
Medical outpatient clinic, University Hospital of Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
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Principal Investigator: Serge de Valliere, MD Medical Outpatient Clinic, University Hospital of Lausanne
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Serge de Valliere, Consultant, University of Lausanne Hospitals Identifier: NCT00821626    
Other Study ID Numbers: PMU-Flu
First Posted: January 13, 2009    Key Record Dates
Results First Posted: April 2, 2020
Last Update Posted: April 2, 2020
Last Verified: March 2020
Keywords provided by Serge de Valliere, University of Lausanne Hospitals:
Rapid flu test
Returning travelers with fever
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases