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| Sponsored by: |
University of Lausanne Hospitals |
|---|---|
| Information provided by: | University of Lausanne Hospitals |
| ClinicalTrials.gov Identifier: | NCT00821626 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment |
| Official Title: | Utility of Rapid Flu Tests in the Medical Management of Returning Travelers With Fever |
| Estimated Enrollment: | 450 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Rapid test: Active Comparator
Returning travelers with fever will have a rapid flu test
|
Device: BD Directigen EZ Flu A+B
Naso-pharyngeal swab and rapid flu test
|
|
Comparator: Sham Comparator
Returning travelers with fever will benefit of the usual medical care, without rapid flu test
|
Other: Control
No rapid flu test
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Serge de Valliere, MD, Msc | +41 21 314 48 52 | serge.de-valliere@hospvd.ch |
| Switzerland | |
| Medical outpatient clinic, University Hospital of Lausanne | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Serge de Valliere, MD +41 21 314 48 52 serge.de-valliere@hospvd.ch | |
| Sub-Investigator: Philippe Staeger, MD | |
| Sub-Investigator: Pascal Meylan, MD | |
| Sub-Investigator: Blaise Genton, MD | |
| Principal Investigator: Serge de Valliere, MD | |
| Tropical Institute Basel | Recruiting |
| Basel, Switzerland, 4002 | |
| Contact: Christoph Hatz, MD christoph.hatz@unibas.ch | |
| Principal Investigator: Christoph Hatz, MD | |
| Principal Investigator: | Serge de Valliere, MD | Medical Outpatient Clinic, University Hospital of Lausanne |
More Information
| Responsible Party: | Medical Outpatient Clinic ( Serge de Vallière, MD, MSc ) |
| Study ID Numbers: | PMU-Flu |
| Study First Received: | January 12, 2009 |
| Last Updated: | January 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00821626 |
| Health Authority: | Switzerland: Ethikkommission |
|
Influenza Rapid flu test Returning travelers with fever |
|
Virus Diseases Fever Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
|
RNA Virus Infections |
