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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid test | Active Comparator | Returning travelers with fever will have a rapid flu test |
|
| Comparator | Sham Comparator | Returning travelers with fever will benefit of the usual medical care, without rapid flu test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD Directigen EZ Flu A+B | Device | Naso-pharyngeal swab and rapid flu test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cost for the Medical Management of Patients | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Chest X-ray Requested | Number of patients for whom a chest X-ray was requested as part of the medical management | 4 years |
| Number of Patients Receiving a Prescription for Antibiotics | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serge de Valliere, MD | Medical Outpatient Clinic, University Hospital of Lausanne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tropical Institute Basel | Basel | 4002 | Switzerland | |||
| Medical outpatient clinic, University Hospital of Lausanne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26358968 | Derived | 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. |
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Participants were recruited between January 2009 and November 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rapid Test | Returning travelers with fever will have a rapid flu test BD Directigen EZ Flu A+B done on a a naso-pharyngeal swab |
| FG001 | Comparator | Returning travelers with fever will benefit of the usual medical care, without rapid flu test |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rapid Test | Returning travelers with fever will have a rapid flu test BD Directigen EZ Flu A+B done on a naso-pharyngeal swab |
| BG001 | Comparator | Returning travelers with fever will benefit of the usual medical care, without rapid flu test |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cost for the Medical Management of Patients | Posted | Mean | 95% Confidence Interval | USD | 4 years |
|
|
4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rapid Test | Returning travelers with fever will have a rapid flu test (BD Directigen EZ Flu A+B) on a naso-pharyngeal swab |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Serge de Vallière | Infectious Disease Service, and Travel Clinic, University Hospital of Lausanne, Switzerland | +41 79 556 43 12 | serge.de-valliere@unisante.ch |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Control | Other | No rapid flu test |
|
| Lausanne |
| 1011 |
| Switzerland |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Chest X-ray Requested | Number of patients for whom a chest X-ray was requested as part of the medical management | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Patients Receiving a Prescription for Antibiotics | Posted | Count of Participants | Participants | 4 years |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Comparator | Returning travelers with fever will benefit of the usual medical care, without rapid flu test | 0 | 33 | 0 | 33 | 0 | 33 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |