INSIGHT Influenza Outpatient Study (FLU 002)

• Death or Hospitalization [ Time Frame: 14-day period following enrollment ] [ Designated as safety issue: No ]
  Death or hospitalization within 14 days of enrollment or the development of one severe complication.
  
  

• Days of work/school lost, duration of symptoms, use of antivirals [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  

The purpose of this observational study is to describe participants in geographically diverse locations with influenza virus infection and their clinical course over a 14-day period following enrollment. Specific objectives are, among patients seeking medical care, to estimate the percentage of patients who go on to develop severe disease or complications that require hospitalization; to obtain information on risk factors for disease severity; 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.

Study Plan:

• Sites will be opened to enrollment when influenza, of any type, is widely circulating in the community of the participating site.
• Persons with influenza-like illness will be consecutively enrolled at participating clinical sites.
• 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 specimen will be sent for central RT-PCR testing for influenza.
• Status will be re-assessed at approximately 14 days after enrollment and another blood sample for serum and plasma will be obtained.

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 002 sites are given the option to also participate in FLU 004 which requires a separate protocol registration. Participants, once consented to FLU 002, will be offered the option to also consent to FLU 004 Genomics which includes a single whole blood sample collection. Participation in FLU 002 will not be compromised if a participant opts not to participate in FLU 004 Genomics.