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Completed

NCT Number: NCT00821626

Rapid Flu Tests in Travelers With Fever

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tropical Institute Basel, Basel, Switzerland

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BD Directigen EZ Flu A+B

Device

Naso-pharyngeal swab and rapid flu test

Other names: BD Directigen EZ Flu A+B, serial number 8010589

Control

Other

No rapid flu test

Primary outcomes

  1. Cost for the Medical Management of Patients

    Time frame: 4 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

Utility of Rapid Flu Tests in the Medical Management of Returning Travelers With Fever

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2009
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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