INSIGHT Influenza Hospitalization Study (FLU 003)
The "flu" is a common disease and usually mild, but severe disease and death may occur. There are several types of flu viruses and they change over time. In 2009 a new influenza A virus, known commonly as swine flu or H1N1v, emerged. This flu virus spread rapidly around the world. However, by November 2010 it became clear in the northern hemisphere that while 2009 pandemic H1N1 virus was still circulating, it was not always the dominant virus in many locations; enrollment of participants was opened to include times when 2009 H1N1 virus was circulating, even if it was not the dominant subtype. Version 2.0 of the protocol (issued June 2011) expanded this further to enrollment of participants with confirmed or suspected influenza of any type. It is important to understand the course of illness for those who have influenza and the characteristics of people who do not do well. The investigators will also try to learn more about how different treatments and prior vaccination for the flu affects the course of the illness. The results of this study will be used to advise on the management of patients who are hospitalized with the flu.
(Influenza A and Subtypes Such as H3N2 and 2009 H1N1 or Influenza B)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An International Observational Study to Characterize Adults Who Are Hospitalized With Complications of Influenza|
- Death [ Time Frame: 60-day period following enrollment ] [ Designated as safety issue: No ]
- Recovery from influenza illness (including days lost from normal activities) duration of hospitalization, days in intensive care, days of mechanical ventilation, days of dialysis, pregnancy outcome [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum, plasma, respiratory
Whole blood for human genomics (only for FLU 003 sites opting to also participate in FLU 004 Genomics and participant has signed an additional consent)
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
The purpose of this observational study is to describe the characteristics and outcomes over a 60-day follow-up period of participants with influenza virus infection (including influenza A subtypes such as H3N2 and 2009 H1N1, or influenza B) who are hospitalized with severe illness and/or complications in geographically diverse locations. Specific objectives are to determine the percentage of patients who die or develop other adverse outcomes following hospitalization for complications associated with influenza, to obtain information on risk factors for mortality and other adverse outcomes, and to establish a central repository of specimens for use in virus characterization, including subtyping, antigenic and genetic analyses, identification of signature mutations associated with antiviral drug resistance, mutational evolution, and additional reassortment. This information will be used to guide policymakers and to design future studies.
Sample size is open-ended for this observational study. As many participants as possible will be enrolled during each influenza season. Enrollment will continue until the funder and/or protocol team determines that the scientific objectives have been met. Approximately 75 sites in geographically diverse locations across 6 continents, where influenza has been circulating broadly in the community, will enroll participants.
- Participating clinical sites will be opened to enrollment when influenza, of any type, is widely circulating in the community.
- Patients with a diagnosis of influenza (confirmed or suspected), who are hospitalized with complications or severe disease, will be enrolled.
- At enrollment, consent is signed and information (demographics, medical history (including prior influenza and pneumococcal vaccination), medications (including antivirals) and treatments prescribed) will be recorded. A blood sample for serum and plasma will be obtained at enrollment, as well as an upper respiratory tract specimen. The respiratory specimens will be sent for central RT-PCR testing for influenza.
- For participants who are still hospitalized, and not intubated, 5 to 7 days after enrollment an additional upper respiratory sample is obtained.
- Status will be re-assessed at approximately 28 days and 60 days after enrollment and another blood sample for serum and plasma will obtained at both time points.
- For participants who are mechanically ventilated additional upper and lower respiratory tract specimens will be obtained at specific time points.
In February 2012, the FLU 004 Genomics protocol was released to the field. The purpose of this study is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other genetic variants that may be associated with an increased risk of severe influenza. Participating FLU 003 sites are given the option to also participate in FLU 004 which requires a separate protocol registration. Participants, once consented to FLU 003, will be offered the option to also consent to FLU 004 Genomics which includes a single whole blood sample collection. Participation in FLU 003 will not be compromised if a participant opts not to participate in FLU 004 Genomics.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056185
|Contact: James Neaton, Professoremail@example.com|
|Contact: Gregg S Larson, Coordinatorfirstname.lastname@example.org|
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|Principal Investigator:||James Neaton, Professor||University of Minnesota - Dept Biostatistics|