Clincosm LogoSign in Get a demo

Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT01011582
Collaborator
(none)
4
Enrollment
1
Location
7
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to collect information on problems that patients with the novel H1N1 influenza and/or the seasonal influenza experience. Novel H1N1 flu is also called the swine flu. Seasonal influenza is also called the regular flu. The purpose of this study is to collect information from patients who are infected with either the novel H1N1 or the seasonal flu and to determine what makes patients critically ill with these infections. The goal is to develop a registry that will aid investigators in determining specific markers that lead to development of severe illness in these infections.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients admitted to the medical intensive care unit with either novel H1N1 infection or seasonal influenza infection may be eligible for participation.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    4 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Human Subjects Registry of Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza
    Study Start Date :
    Nov 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2010
    Actual Study Completion Date :
    Jun 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Novel H1N1 influenza
    Seasonal influenza

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome is to contrast patients infected with novel H1N1 influenza to those infected with seasonal influenza. [Patients will be evaluated until May 31, 2010]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients admitted to the medical intensive care unit with a diagnosis of novel H1N1 influenza infection or with a diagnosis of seasonal influenza infection.
    Exclusion Criteria:

    • Prisoners

    • Refusal of study participation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia) Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Virginia Commonwealth University

    Investigators

    • Principal Investigator: Marjolein de Wit, M.D., M.S., Virginia Commonwealth University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT01011582
    Other Study ID Numbers:
    • VCU IRB HM12562
    First Posted:
    Nov 11, 2009
    Last Update Posted:
    Jan 8, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Virginia Commonwealth University
    To evaluate biomarkers that cause critical illness in patients with novel H1N1 influenza and with seasonal influenza.
    Additional relevant MeSH terms:
    Influenza, Human

    Study Results

    No Results Posted as of Jan 8, 2013