FLU 002 Plus
An International Observational Study to Characterize Adults with Influenza or Other Targeted Respiratory Viruses
Observing, over 14 days, the effects of flu on people seen at their GP.
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 describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment.
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
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 – April 2017
Where is it taking place?
FLU 002 Plus was an international study, with multiple sites in the Northern and Southern Hemisphere. 11,719 patients were enrolled across 17 countries. The MRC CTU oversaw 8 sites in the UK and 8 sites Greece who between them enrolled 521 patients.
Who is included?
To be eligible for enrolment participants must be ≥ 18 years of age, have a signed informed consent, and the following:
- Fever (≥ 37.8° C or 100° F) on examination or patient-reported fever (≥ 37.8° C or 100° F) or feverishness (felt febrile but did not take temperature) in the past 24 hours
- Cough and/or sore throat
- Suspected influenza or a suspected targeted non influenza viral respiratory infection