Rapid Flu Tests in Travelers With Fever

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Serge de Valliere, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00821626
First received: January 12, 2009
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Influenza
Device: BD Directigen EZ Flu A+B
Other: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Utility of Rapid Flu Tests in the Medical Management of Returning Travelers With Fever

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Difference in utilization of diagnostic tests and anti-infective drugs between the group with rapid flu test and the group without flu test [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821626

Locations
Switzerland
Tropical Institute Basel
Basel, Switzerland, 4002
Medical outpatient clinic, University Hospital of Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Serge de Valliere, MD Medical Outpatient Clinic, University Hospital of Lausanne
  More Information

No publications provided

Responsible Party: Serge de Valliere, Consultant, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00821626     History of Changes
Other Study ID Numbers: PMU-Flu
Study First Received: January 12, 2009
Last Updated: August 4, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
Influenza
Rapid flu test
Returning travelers with fever

ClinicalTrials.gov processed this record on September 15, 2014