FLU 003 Plus
In 2009, the world experienced the first global influenza (flu) pandemic in 40 years. This study was initiated to better understand the risk factors for severe infection and poor outcomes in people hospitalised with 2009 influenza virus infection in diverse locations. Since then, the study has been further expanded to include other influenza viruses and novel respiratory viruses such as Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) that could become prevalent and of major public health importance.
Data gathered from this study will help us understand the characteristics and outcomes of individuals hospitalised with influenza virus types and subtypes over time and by geographically location. A central repository will enable virus characterisation, including subtyping, antigenic and genetic analyses, identification of signature mutations associated with antiviral drug resistance, mutational evolution, and additional re-assortment. Information collected from individuals with a novel respiratory virus infection will help us understand possible sources of infection, modes of transmission, and patient outcomes.
This prospective observational study will enrol individuals hospitalised with suspected or confirmed influenza virus infection or a targeted novel respiratory virus infection at clinical sites in Europe, North and South America, Asia, and Australia. Participants are followed for 60 days for survival and other clinical outcomes. To date, a total of 2,897 participants have been recruited internationally.
Data published to date reinforce the need for international trials of novel treatment strategies and serve as a reminder of the need to monitor the severity of seasonal and pandemic influenza vaccines globally.
The information will help guide policymakers and aid in the design of future influenza studies. Information from individuals with a novel respiratory virus infection may help inform clinical management and policy decisions in relation to the threat of future pandemics.
- International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
- University of Minnesota – Clinical and Translational Science Institute – Minnesota, USA
- Copenhagen HIV Programme (CHIP) – Copenhagen, Denmark
- Medical Research Council (MRC) Clinical Trials Unit – London, United Kingdom
- The Institute for Clinical Research at the Veterans Affairs Medical Center – Washington, D.C., USA
