An International Observational Study to Characterize Adults Who Are Hospitalized With Complications of Influenza


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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. Study Plan: - 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.

Who is eligible to participate?

Inclusion Criteria: - Signed informed consent by participant or surrogate/representative - Local diagnosis of influenza(confirmed or suspect) - Age at least 18 years - Hospitalized for severe and/or complicated influenza defined as one or more of the following: - Respiratory distress requiring supplemental oxygen - Exacerbation of a pre-existing medical condition - Circulatory collapse defined as requirement for vasopressor support despite adequate hydration - Acute renal dysfunction or failure - Acute liver dysfunction or failure - Pregnancy-related complications, e.g., premature labor - Other severe organ dysfunction, e.g., encephalitis, meningitis, peripheral neurological disease, myocarditis, enteritis, myositis, or invasive bacterial infection Exclusion Criteria: - Current imprisonment, or compulsory detention (involuntary incarceration) for treat of a psychiatric or physical illness.

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