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| Sponsor: | Virginia Commonwealth University |
|---|---|
| Information provided by: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01011582 |
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 |
Blood specimens and sputum specimens will be collected.
| Estimated Enrollment: | 75 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Novel H1N1 influenza |
| Seasonal influenza |
Patients admitted to the medical intensive care unit with either novel H1N1 infection or seasonal influenza infection may be eligible for participation.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients admitted to the medical intensive care unit at Virginia Commonwealth University Medical Center, Richmond, Virginia.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Marjolein de Wit, MD, MS | 804-828-9071 | mdewit@mcvh-vcu.edu |
| Contact: Herman J. Bogaard, MD, PhD | 804-828-9071 | hjbogaard@vcu.edu |
| United States, Virginia | |
| Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia) | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Marjolein de Wit, MD, MS 804-828-9071 mdewit@mcvh-vcu.edu | |
| Contact: Herman J Bogaard, MD, PhD 804-828-9071 hjbogaard@vcu.edu | |
| Principal Investigator: Marjolein de Wit, MD, MS | |
| Sub-Investigator: Herman J Bogaard, MD, PhD | |
| Principal Investigator: | Marjolein de Wit, M.D., M.S. | Virginia Commonwealth University |
More Information
| Responsible Party: | Marjolein de Wit, MD, MS, Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01011582 History of Changes |
| Other Study ID Numbers: | VCU IRB HM12562 |
| Study First Received: | November 9, 2009 |
| Last Updated: | July 1, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
To evaluate biomarkers that cause critical illness in patients with novel H1N1 influenza and with seasonal influenza. |
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
