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Novel Influenza A (H1N1) Surveillance Registry

13. april 2016 oppdatert av: National Heart, Lung, and Blood Institute (NHLBI)
The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden of disease and resource utilization of these patients remains largely unknown. The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

894

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alaska
      • Anchorage, Alaska, Forente stater
        • Alaska Native Medical Center
      • Anchorage, Alaska, Forente stater
        • The Children's Hospital at Providence
    • Arizona
      • Phoenix, Arizona, Forente stater
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, Forente stater
        • Arkansas Children's Hiospital
    • California
      • Fresno, California, Forente stater
        • University of San Francisco-Fresno Medical Center
      • Los Angeles, California, Forente stater
        • Children's Hospital Los Angeles
      • Oakland, California, Forente stater
        • Children's Hospital and Research Center Oakland
      • Orange, California, Forente stater
        • Children's Hospital of Orange County
      • Sacramento, California, Forente stater
        • University of California, Davis Medical Center
      • San Francisco, California, Forente stater
        • UCSF-Moffitt Hospital
      • San Francisco, California, Forente stater
        • UCSF-San Francisco General Hospital
      • San Francisco, California, Forente stater
        • University of California, San Francisco (UCSF)-Moffitt Hospital
      • San Francisco, California, Forente stater
        • UCSF Children's Medical Center
    • Colorado
      • Aurora, Colorado, Forente stater
        • Denver's Children Hospital
      • Denver, Colorado, Forente stater
        • University of Colorado Health Sciences Center
      • Denver, Colorado, Forente stater
        • Centura St. Anthony Central Hospital
      • Denver, Colorado, Forente stater
        • Denver Health Medical Center
      • Denver, Colorado, Forente stater
        • Rose Medical Center
    • Connecticut
      • Hartford, Connecticut, Forente stater
        • Connecticut Children's Medical Center
      • New Haven, Connecticut, Forente stater
        • Yale-New Haven Children's Hospital
    • District of Columbia
      • Washington, District of Columbia, Forente stater
        • Children's National Medical Center
      • Washington DC, District of Columbia, Forente stater
        • Washington Hospital Center
    • Florida
      • Jacksonville, Florida, Forente stater
        • Mayo Clinic at Jacksonville
      • Miami, Florida, Forente stater
        • Miami Children's Hospital
      • Miami, Florida, Forente stater
        • Holt'z Children's Hospital
    • Georgia
      • Atlanta, Georgia, Forente stater
        • Children's Healthcare of Atlanta at Egleston
    • Hawaii
      • Honolulu, Hawaii, Forente stater
        • Kapi'olani Center for Women and Children
    • Illinois
      • Chicago, Illinois, Forente stater
        • Children's Memorial Hospital
    • Kentucky
      • Louisville, Kentucky, Forente stater
        • Kosair Children's Hospital
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater
        • Earl K. Long Medical Center
      • Baton Rouge, Louisiana, Forente stater
        • Our Lady of the Lake Regional Medical Center
      • New Orleans, Louisiana, Forente stater
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, Forente stater
        • Medical Center of Louisiana
      • New Orleans, Louisiana, Forente stater
        • Tulane University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, Forente stater
        • Johns Hopkins Bayview Medical Center
      • Baltimore, Maryland, Forente stater
        • Johns Hopkins Hospital
      • Baltimore, Maryland, Forente stater
        • University of Maryland Shock Trauma Center
      • Baltimore, Maryland, Forente stater
        • Johns Hopkins Children's Center
      • Baltimore, Maryland, Forente stater
        • Union Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, Forente stater
        • Children's Hospital Boston
      • Boston, Massachusetts, Forente stater
        • Boston Medical Center
      • Springfield, Massachusetts, Forente stater
        • Baystate Medical Center
    • Michigan
      • Grand Rapids, Michigan, Forente stater
        • Helen DeVos Children's Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forente stater
        • Children's Hospital and Clinics of Minnesota
      • Minneapolis, Minnesota, Forente stater
        • University of Minnesota Children's Hospital
      • Rochester, Minnesota, Forente stater
        • Rochester Methodist Hospital
      • Rochester, Minnesota, Forente stater
        • St. Mary's Hospital, Mayo Clinic
    • Missouri
      • St. Louis, Missouri, Forente stater
        • St. Louis Children's Hospital
      • St. Louis, Missouri, Forente stater
        • SSM Cardinal Glennon Children's Medical Center
    • Nebraska
      • Omaha, Nebraska, Forente stater
        • Children's Hospital of Nebraska
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater
        • Darthmouth-Hitchcock Medical Center
    • New York
      • Bronx, New York, Forente stater
        • Children's Hospital of Montefiore
      • Rocherster, New York, Forente stater
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater
        • University of North Carolina
      • Durham, North Carolina, Forente stater
        • Duke University Medical Center
      • Durham, North Carolina, Forente stater
        • Durham Regional Medical Center
      • Durham, North Carolina, Forente stater
        • Duke University Children's Hospital
      • Greensboro, North Carolina, Forente stater
        • Moses Cone Health System
      • Greensboro, North Carolina, Forente stater
        • Wesley Long Community Hospital
      • Winston Salem, North Carolina, Forente stater
        • Wake Forest University Baptist Medical Center
    • Ohio
      • Cleveland, Ohio, Forente stater
        • University Hospitals of Cleveland
      • Cleveland, Ohio, Forente stater
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Forente stater
        • MetroHealth Medical Center
      • Columbus, Ohio, Forente stater
        • Nationwide Children' Hospital
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater
        • Children's Hospital at St. Francis
    • Oregon
      • Portland, Oregon, Forente stater
        • Doernbecher Children's Hospital
    • Pennsylvania
      • Hershey, Pennsylvania, Forente stater
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, Forente stater
        • The Children's Hospital of Philadelphia
    • Tennessee
      • Nashville, Tennessee, Forente stater
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, Forente stater
        • Monroe Carell Children's Hospital at Vanderbilt
    • Texas
      • Austin, Texas, Forente stater
        • Dell Children's Medical Center of Central Texas
      • Dallas, Texas, Forente stater
        • University of Texas Southwestern Children's Medical Center
      • Houston, Texas, Forente stater
        • Texas Children's Hospital
      • Houston, Texas, Forente stater
        • Baylor College of Medicine
    • Utah
      • Murray, Utah, Forente stater
        • Intermountain Medical Center
      • Ogden, Utah, Forente stater
        • McKay-Dee Hospital
      • Provo, Utah, Forente stater
        • Utah Valley Regional Medical Center
      • Salt Lake City, Utah, Forente stater
        • LDS Hospital
      • Salt Lake City, Utah, Forente stater
        • Primary Children's Medical Center
    • Virginia
      • Charlottesville, Virginia, Forente stater
        • University of Virginia Medical Center
      • Charlottesville, Virginia, Forente stater
        • University of Virginia Children's Medical Center
    • Washington
      • Everett, Washington, Forente stater
        • Providence Hospital
      • Seattle, Washington, Forente stater
        • University of Washington
      • Seattle, Washington, Forente stater
        • Seattle Children's Hospital
      • Seattle, Washington, Forente stater
        • Harborview Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater
        • Children's Hospital of Wisconsin

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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.

Beskrivelse

Inclusion Criteria:

  • Admission to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection

Exclusion Criteria:

  • Influenza-like illness due to non-influenza disease and negative testing for influenza

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
Adult H1N1
Patients admitted to adult ICU with confirmed or suspected H1N1 Influence infection
Pediatric H1N1
Patients admitted to pediatric ICU with confirmed or suspected H1N1 Influenza infection

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Etterforskere

  • Hovedetterforsker: Todd W Rice, MD, MSc, Vanderbilt University
  • Hovedetterforsker: B. Taylor Thompson, MD, Massachusetts General Hospital
  • Hovedetterforsker: Adrienne G Randolph, MD, MSc, Boston Children's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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. oktober 2009

Primær fullføring (Faktiske)

1. april 2010

Studiet fullført (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først innsendt

8. januar 2010

Først innsendt som oppfylte QC-kriteriene

8. januar 2010

Først lagt ut (Anslag)

12. januar 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. april 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. april 2016

Sist bekreftet

1. november 2010

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 688
  • N01HR056179 (Annet stipend/finansieringsnummer: NIH Contract Number)
  • HSN268200536179C (Annet stipend/finansieringsnummer: NIH Contract Number)

Plan for individuelle deltakerdata (IPD)

Studiedata/dokumenter

  1. Datasett for individuell deltaker
    Informasjonsidentifikator: H1N1
    Informasjonskommentarer: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
  2. Studieskjemaer

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. .

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Mauritania

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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