Novel Influenza A (H1N1) Surveillance Registry
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The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden of disease and resource utilization of these patients remains largely unknown. The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.
Condition |
---|
Novel Influenza A H1N1 Influenza |
Study Type: | Observational |
Study Design: | Observational Model: Cohort |
Official Title: | Novel Influenza A (H1N1) Surveillance Registry |
Enrollment: | 894 |
Study Start Date: | October 2009 |
Study Completion Date: | October 2010 |
Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
---|
Adult H1N1
Patients admitted to adult ICU with confirmed or suspected H1N1 Influence infection
|
Pediatric H1N1
Patients admitted to pediatric ICU with confirmed or suspected H1N1 Influenza infection
|
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.
Inclusion Criteria:
- Admission to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection
Exclusion Criteria:
- Influenza-like illness due to non-influenza disease and negative testing for influenza
Show 86 Study Locations
Principal Investigator: | B. Taylor Thompson, MD | Massachusetts General Hospital |
Principal Investigator: | Adrienne G Randolph, MD, MSc | Children's Hospital Boston |
Principal Investigator: | Todd W Rice, MD, MSc | Vanderbilt University |
Additional Information:
No publications provided
Responsible Party: | Andrea Harabin, National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT01046331 History of Changes |
Other Study ID Numbers: | 688, N01HR056179, HSN268200536179C |
Study First Received: | January 8, 2010 |
Last Updated: | November 9, 2010 |
Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on February 14, 2013