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Trial record 2 of 19 for:    H1N1 and Durham

Novel Influenza A (H1N1) Surveillance Registry

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.
 
ClinicalTrials.gov Identifier: NCT01046331
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : April 14, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date January 8, 2010
First Posted Date January 12, 2010
Last Update Posted Date April 14, 2016
Study Start Date October 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Novel Influenza A (H1N1) Surveillance Registry
Official Title Novel Influenza A (H1N1) Surveillance Registry
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.
Condition
  • Novel Influenza A
  • H1N1
  • Influenza
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 9, 2010)
894
Original Estimated Enrollment
 (submitted: January 8, 2010)
2000
Actual Study Completion Date October 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01046331
Other Study ID Numbers 688
N01HR056179 ( Other Grant/Funding Number: NIH Contract Number )
HSN268200536179C ( Other Grant/Funding Number: NIH Contract Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andrea Harabin, National Heart, Lung, and Blood Institute (NHLBI)
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Principal Investigator: B. Taylor Thompson, MD Massachusetts General Hospital
Principal Investigator: Adrienne G Randolph, MD, MSc Boston Children's Hospital
Principal Investigator: Todd W Rice, MD, MSc Vanderbilt University
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date November 2010