- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00421837
Pilot Study of Genotypic Analysis
15. august 2013 oppdatert av: National Institute of Allergy and Infectious Diseases (NIAID)
Pilot Study of the Genotypic Analysis of Patients Infected With Influenza Virus Compared With Uninfected Spouse/Close Contact Controls
Influenza (the flu) is a leading cause of respiratory (breathing) illness that leads to sickness and death during the winter months.
A better understanding of why certain people get the flu or get sicker with the flu than other people is important for developing improved vaccines and treatments.
This study will look at the genetic makeup (determines each person's specific characteristics and traits) of 50 patients, older than 50, who were hospitalized with flu at Vanderbilt University during the 2006-2007 flu season.
Their genetic makeup will be compared with the genetic makeup of 50 people who are not related but were in close daily contact with the flu patient and were not infected with flu virus.
The study staff will collect a blood sample (contains genetic material) from each participant (flu patients and their contacts) for comparison.
Flu patients will have completed a health survey as part of the previous study, and their contacts will complete a shorter version of this survey.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Influenza is a leading vaccine preventable cause of respiratory illness that leads to substantial morbidity and mortality during the winter months.
It is defined by a rapid-onset systemic illness, with patients presenting with fever, chills, cough, myalgias, headache and sore throat.
Given the huge health burden caused by influenza and the ever present threat of a future pandemic, a better understanding of population genetic variation and its association with severe outcomes from influenza infection is critical for developing improved vaccines and treatments for the entire population of at risk persons.
This study is a single-center, specimen collection pilot protocol designed to compare the genotype of patients, aged greater than 50 years, who are hospitalized with respiratory symptoms or fever at Vanderbilt University with culture or PCR confirmed influenza virus infection with individuals who are not related but are in close daily contact with the subject and are not infected with influenza virus during the 2006 - 2007 influenza season.
This study is linked to DMID protocol 06-0051.
All subjects will be recruited from those subjects who have been enrolled in Division of Microbiology and Infectious Diseases (DMID) parent study 06-0051, a Vaccine and Treatment Evaluation Units (VTEU)-funded respiratory disease surveillance study conducted during the 2006 - 2007 influenza season.
If the subject has completed the surveillance parent study, (DMID study 06-0051), then he/she must have agreed to be contacted for future studies on the surveillance consent prior to enrollment into this sub-study.
Controls for this study will be recruited via the index cases.
This study will enroll 100 subjects total, 50 study subjects and 50 control subjects.
The 50 study subjects will include individuals hospitalized with respiratory symptoms or fever and infected with influenza virus.
The 50 control subjects will be uninfected, non-related individuals living in the same household or in close daily contact with the subject.
The study staff will obtain 15 ml venous blood sample from each subject for genotyping studies.
Subjects will have completed a health assessment as part of the parent trial and controls will be asked a shorter version of this survey which includes items such as: demographics, chronic disease history, history of immunosuppressive drugs or conditions, vaccination history, smoking history, and living conditions.
The primary objectives of the study are to conduct whole genome array analysis on individuals with confirmed influenza virus infection and to compare their genotype with individuals who were likely exposed to influenza due to close daily contact, but are not genetically related.
Studietype
Observasjonsmessig
Registrering (Faktiske)
6
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Tennessee
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Nashville, Tennessee, Forente stater, 37232-2573
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Subjects > 55 yo hospitalized with Influenza vs healthy household members and close contacts
Beskrivelse
Inclusion Criteria:
- Male or female, aged greater than or equal to 50 years
- For SUBJECTS: Enrolled in a Vaccine Treatment and Evaluation Unit (VTEU)-funded surveillance study conducted during the 2006 - 2007 influenza season [Division of Microbiology and Infectious Diseases (DMID) study 06-0051]
- Residents of surveillance areas
- For SUBJECTS: Persons who have been hospitalized with respiratory symptoms or fever and polymerase chain reaction (PCR) or culture confirmed influenza virus OR
- For CONTROLS: Living with or in frequent contact with SUBJECT
- For CONTROLS: Genetically unrelated to the SUBJECT
- Willing and able to provide signature documentation of informed consent or parental permission
Exclusion Criteria:
- For SUBJECTS: Not enrolled in a Vanderbilt led respiratory disease surveillance study [Division of Microbiology and Infectious Diseases (DMID) study 06-0051]
- For SUBJECTS: Receipt of blood products in the past 6 months
- Anything in the opinion of the Investigator that would prevent the subject from successfully participating in this study
- For CONTROLS: Influenza infection during the 2006-2007 flu season
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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controls
household and other close contacts
|
cases
elderly (>55) subjects hospitalized with Influenza
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
phenotypic analysis
Tidsramme: at analysis
|
at analysis
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2007
Primær fullføring (Faktiske)
1. desember 2008
Studiet fullført (Faktiske)
1. desember 2008
Datoer for studieregistrering
Først innsendt
11. januar 2007
Først innsendt som oppfylte QC-kriteriene
11. januar 2007
Først lagt ut (Anslag)
12. januar 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. august 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. august 2013
Sist bekreftet
1. april 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 06-0092
- N01AI80007C
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