Molecular point-of-care 'test and treat' for influenza (FluPOC) v1.0
Research type
Research Study
Full title
Pragmatic randomised controlled trial evaluating a routine molecular Point-of-Care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness: FluPOC
IRAS ID
229629
Contact name
Tristan W Clark
Contact email
Sponsor organisation
R&D, University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
8 years, 0 months, 1 days
Research summary
Background
Influenza causes severe illness in up to 5 million people and deaths in around half a million people per year worldwide. Respiratory viruses are the most commonly detected pathogens in adults hospitalised with acute respiratory illness (ARI).
Influenza and other respiratory virus infections often remain undiagnosed in hospitalised patients due to lack of routine testing. When tested for, diagnosis and treatment are often delayed because of slow laboratory turnaround times.
Neuraminidase inhibitors (NAIs) such as oseltamivir (Tamiflu) are recommended by Public Health England for all hospitalised adults with suspected and proven influenza infection. Well controlled observational data suggest that NAIs reduce mortality in hospitalised adults with influenza especially when commenced rapidly.New molecular platforms, such as the FilmArray Respiratory Panel, have comparable sensitivity to laboratory testing, are easy to use, and generate a result in one hour, making them deployable as POCTs. Our previous study suggests that routine molecular POC testing for respiratory viruses in hospitalised adults with ARI improves influenza detection, antiviral use and infection control measures however further corroborative studies are needed before this technology can be adopted throughout the NHS.
Aim
This study will evaluate the impact of a routine molecular point-of-care ‘test and treat’ strategy for influenza in adults hospitalised with acute respiratory illness.
Methods
We will undertake a pragmatic, randomised controlled trial in adults with ARI admitted to University Hospital Southampton NHS Foundation Trust. 840 patients will be recruited over three influenza seasons and randomised (1:1) to receive either POCT using the FilmArray Respiratory Panel, or routine clinical care. Results will be given to clinical and infection control teams immediately. Where influenza is detected patients will be offered NAI treatment immediately, in-line with national guidelines. The outcome measures include the proportion of influenza-positive patients detected and appropriately treated with NAIs, isolation facility use, antibiotic use, hospital stay duration, complications and mortality.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0368
Date of REC Opinion
7 Sep 2017
REC opinion
Further Information Favourable Opinion