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

Seasonal Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011582
• Other study ID #: VCU IRB HM12562
• Status: Completed
• Phase: N/A
• First received: November 9, 2009
• Last updated: January 7, 2013
• Start date: November 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2013
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• H1N1 Influenza
• Influenza, Human
• Seasonal Influenza

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No