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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01011582
First Posted: November 11, 2009
Last Update Posted: January 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
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
H1N1 Influenza Seasonal Influenza

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • The primary outcome is to contrast patients infected with novel H1N1 influenza to those infected with seasonal influenza. [ Time Frame: Patients will be evaluated until May 31, 2010 ]

Biospecimen Retention:   Samples Without DNA
Blood specimens and sputum specimens will be collected.

Enrollment: 4
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Novel H1N1 influenza
Seasonal influenza

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the medical intensive care unit at Virginia Commonwealth University Medical Center, Richmond, Virginia.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011582


Locations
United States, Virginia
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
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01011582     History of Changes
Other Study ID Numbers: VCU IRB HM12562
First Submitted: November 9, 2009
First Posted: November 11, 2009
Last Update Posted: January 8, 2013
Last Verified: January 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
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases