PRJ2956 - IVZ post-marketing effectiveness

Trial description: Influenza infection continues to be an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality annually. It is recognized that there are limited options for the treatment of influenza in both adults and children. Neuraminidase inhibitors (NAIs) have been shown to be effective for the treatment of seasonal influenza, but the threat of antiviral drug resistance remains. Furthermore, there is an unmet medical need for participants who are unable to take oral or actively inhaled medications, or where systemic exposure beyond the respiratory tract is required, highlighting the need for intravenous (IV) formulations of effective anti-influenza agents to treat adult and pediatric participants with complicated influenza. This retrospective observational chart review study will be conducted as a specific obligation following the grant of the marketing authorization under exceptional circumstances as stated in Article 14 (8) of Regulation ethics committee (EC) number 726/2004 for Dectova (zanamivir) 10 milligram per milliliter (mg/mL) solution for infusion. The clinical outcomes among complicated influenza participants, admitted to ICU treated with Dectova as part of their routine medical care, will be compared with a concurrent cohort of ICU participants who did not receive this therapy. A propensity score matched approach will be used to compare the primary endpoint of all-cause in-hospital mortality between treatment groups. This study will be conducted in selected countries from the European Union (EU), Norway and Iceland.