- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00821626
Rapid Flu Tests in Travelers With Fever
Utility of Rapid Flu Tests in the Medical Management of Returning Travelers With Fever
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Basel, Schweiz, 4002
- Tropical Institute Basel
-
Lausanne, Schweiz, 1011
- Medical outpatient clinic, University Hospital of Lausanne
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Rapid test
Returning travelers with fever will have a rapid flu test
|
Naso-pharyngeal swab and rapid flu test
Andre navne:
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|
Sham-komparator: Comparator
Returning travelers with fever will benefit of the usual medical care, without rapid flu test
|
No rapid flu test
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Cost for the Medical Management of Patients
Tidsramme: 4 years
|
4 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Chest X-ray Requested
Tidsramme: 4 years
|
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
Tidsramme: 4 years
|
4 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Serge de Valliere, MD, Medical outpatient clinic, University Hospital of Lausanne
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PMU-Flu
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