FLU 003 Plus
An international observational study to characterise adults who are hospitalised with influenza or other targeted respiratory viruses
What makes some people more likely to become severely ill from influenza and other respiratory infections?
What is this study about?
Following the sudden and unexpected emergence of influenza A (H1N1) pdm09 (2009 H1N1) virus (sometimes referred to as swine flu), this observational study was initiated to estimate rates of illness and death and to examine predictors of severity among participants with 2009 H1N1 infection.
In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses.
This version of the trial protocol further broadens the scope of this observational study. Recognising that novel respiratory viruses other than novel influenza A viruses, e.g. Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.
Type of study
Observational study
Contact details
Who is funding the study?
The study is funded by the US National Institute of Allergy and Infectious Diseases (NIAID), US National Institutes of Health (NIH) and carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT).
When is it taking place?
The study began in October 2009 and is still ongoing and open to recruitment.
Where is it taking place?
This is an international study, with multiple sites in the northern and southern Hemisphere. As of August 2023, 6,164 patients had been enrolled across 17 countries.
In the UK, there are currently six sites located in Brighton, Oxford, Newcastle, Leeds, Bradford and London. Sites in Manchester, Middlesbrough, Sheffield, Wexham and Edinburgh have also previously participated in the study.
Who is included?
Adults aged 18 or older with signed informed consent (by patient or legal representative), who have either:
• been admitted to hospital
• a local diagnosis (confirmed or suspected) of influenza, or of a targeted non influenza viral respiratory infection, resulting in (or extending a previous) hospitalisation.