- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01024673
Clinical Characteristics and Outcomes in Patients Diagnosed With Novel Influenza A (H1N1)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Patients diagnosed with H1N1 will be asked to consent and allow us to collect the following:
From the medical record the research staff will review and record the results of the test/procedures (x-rays, CT-scans, EKG (electrocardiogram), etc.) that are part of the subjects clinical care and the results will become part of the research record. We will also collect and record vitals signs, including temperature, blood pressure, heart rate, respiratory rate and record the list of medications the subject is taking. We will also collect information on demographics (address, phone number, etc.) including gender, race and ethnicity, review and record past medical history and any non medical procedures that the subject may have had within the past two months. This information will be collected by the research coordinator from the medical record.
The clinical physician ordered a nasopharyngeal swab or obtained bronchoalveolar lavage fluid to diagnose novel Influenza A (H1N1). We will collect this swab or fluid after the diagnosis has been made, to evaluate the genetic material of the virus. This swab or fluid is normally discarded once the diagnosis is made.
collection of data will be done by the research staff and should not take any longer than 15-20 minutes. The clinical samples that would have been discarded will be collected by the research staff from microbiology and pathology and delivered to the research lab in Scaife.
The investigators will do a 6 month follow up phone call to check the health status of the participant. This will be done by the research coordinator and take no more than 5-10 minutes of the subject's time.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213
- UPMC
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients diagnosed with H1N1
Exclusion Criteria:
- does not meet entry criteria
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
patients with H1N1
patients who are clinical found to be positive for H1N1 will be enrolled
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To describe the clinical characteristic and outcomes of the patients admitted to UPMC Presbyterian campus with infection due to novel influenza A (H1N1).
Tidsramme: 5 year
|
5 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To identify risk factors for admission to the ICU and mortality
Tidsramme: 5 years
|
5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB#: PRO09090326
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