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

NCT01011582 | Completed

• 1 other identifier: VCU IRB HM12562
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

H1N1 Influenza; Seasonal Influenza

Keywords

To evaluate biomarkers that cause critical illness in patients with novel H1N1 influenza and with seasonal influenza.

Outcome Measures

Primary Outcomes (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

Study Arms (2)

Novel H1N1 influenza

Seasonal influenza

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the medical intensive care unit at Virginia Commonwealth University Medical Center, Richmond, Virginia.

You may qualify if:

• Patients admitted to the medical intensive care unit with a diagnosis of novel H1N1 influenza infection or with a diagnosis of seasonal influenza infection.

You may not qualify if:

• Prisoners
• Refusal of study participation.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)

Richmond, Virginia, 23298, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood specimens and sputum specimens will be collected.

MeSH Terms

Conditions

Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Marjolein de Wit, M.D., M.S.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

US (1)