- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00821626
Rapid Flu Tests in Travelers With Fever
Utility of Rapid Flu Tests in the Medical Management of Returning Travelers With Fever
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Basel, Sveits, 4002
- Tropical Institute Basel
-
Lausanne, Sveits, 1011
- Medical outpatient clinic, University Hospital of Lausanne
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Rapid test
Returning travelers with fever will have a rapid flu test
|
Naso-pharyngeal swab and rapid flu test
Andre navn:
|
Sham-komparator: Comparator
Returning travelers with fever will benefit of the usual medical care, without rapid flu test
|
No rapid flu test
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cost for the Medical Management of Patients
Tidsramme: 4 years
|
4 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Serge de Valliere, MD, Medical outpatient clinic, University Hospital of Lausanne
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PMU-Flu
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på BD Directigen EZ Flu A+B
-
Ellume Pty LtdFullført
-
DiaSorin Molecular LLCFullførtKoronavirusepidemi 2019 | Influensa A | Influensa type BAustralia
-
Abbott Rapid Diagnostics Jena GmbHFullførtCovid-19 | Influensa A | Influensa type BForente stater
-
LumiraDx UK LimitedHar ikke rekruttert ennåSARS-CoV-2 | Influensa A | Asymptomatisk COVID-19 | Influensa BForente stater
-
Thermo Fisher Scientific, IncNAMSAFullførtSARS-CoV-2-infeksjon | Influensa A | RSV-infeksjon | Influensa type BForente stater
-
Medical Group Care, LLCCSSi Life SciencesFullførtCovid-19 | Influensa A | Influensa BForente stater
-
Abbott Rapid DxFullførtCovid-19 | Influensa A | Influensa type BForente stater
-
LumiraDx UK LimitedSuspendertCovid-19 | SARS-CoV-2 | Influensa A | Influensa BForente stater
-
Abbott Rapid DxFullførtCovid-19 | Influensa A | Influensa type BForente stater
-
Ellume Pty LtdFullført