FLU 003 Plus

An International Observational Study to Characterize Adults Who Are Hospitalized with Influenza or Other Targeted Respiratory Viruses

An International Observational Study to Characterize Adults Who Are Hospitalized with Influenza or Other Targeted Respiratory Viruses

What is this study about?

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality 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 protocol further broadens the scope of this observational study. With the recognition 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

Mrcctu.flustudies@ucl.ac.uk

Who is funding the study?

The National Institute of Allergy and Infectious Diseases (NIAID), 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?

October 2009 – September 2019 (with possible extension)

Where is it taking place?

This is an international study, with multiple sites in the Northern and Southern Hemisphere. As of June 2018 3454 patients have been enrolled across 17 countries since October 2009. In the UK, there are now 6 sites participating. These are located in Brighton, Oxford, Newcastle, Leeds, Bradford, London

Sites in Manchester, Middlesbrough, Sheffield, Wexham and Edinburgh have also previously participated in the study.

Who is included?

To be eligible for enrolment participants must be ≥ 18 years of age, have a signed informed consent (by patient or legal representative), and the following:
- Have been admitted to hospital
- Have a local diagnosis (confirmed or suspected) of influenza, or of a targeted non influenza viral respiratory infection, resulting in (or extending a previous) hospitalization.