Novel Influenza A (H1N1) Surveillance Registry
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| ClinicalTrials.gov Identifier: NCT01046331 |
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Recruitment Status :
Completed
First Posted : January 12, 2010
Last Update Posted : April 14, 2016
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Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
| Tracking Information | ||||||||||
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| 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 |
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| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
894 | |||||||||
| Original Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 ) |
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| 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 |
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| PRS Account | National Heart, Lung, and Blood Institute (NHLBI) | |||||||||
| Verification Date | November 2010 | |||||||||