Zanamivir IV Effectiveness
Research type
Research Study
Full title
A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in a cohort of intensive care unit-treated (ICU) patients with complicated influenza infection.
IRAS ID
275972
Contact name
Laura Gonzalez
Contact email
Sponsor organisation
GlaxoSMithKline Research & Development Limited
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
A retrospective comparative observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in a cohort of intensive care (ICU) patients with complicated influenza infection.
Despite vaccination and available treatments, seasonal influenza accounts for approximately 3-5 million severe infections and 250,000-500,000 deaths worldwide annually.
This study will gain an understanding of the clinical management of complicated influenza in ICUs in Europe. It will also investigate the clinical effectiveness of IV zanamivir (Dectova) in the treatment of patients with complicated influenza in this setting, compared to patients who do not receive treatment with Dectova.
The collection of historical data for influenza seasons 2017/-18 and 2018/-19 will begin after the current influenza season (2019/-20) has finished. The historical part is designed to gain an understanding of the clinical management of complicated influenza in European ICUs. The data collection for the comparative part of the study, to be done in the current (2019/-20) and following influenza season (2020/-21) starts after each of the seasons have finished, to ensure the retrospective nature of this study. Both parts will be conducted in patients infected with influenza and admitted to ICU.
This study will involve patients in ICU with severe influenza in various tertiary hospitals in the United Kingdom and other countries in the European Union.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
20/SW/0053
Date of REC Opinion
6 Apr 2020
REC opinion
Favourable Opinion