Point-of-care testing for respiratory viruses in critical care v1.0
Research type
Research Study
Full title
Pragmatic randomised controlled trial of molecular point-of-care testing for respiratory viruses versus routine clinical care in adults with severe acute respiratory illness: a pilot study (SARIPOC)
IRAS ID
216585
Contact name
Tristan W Clark
Contact email
Sponsor organisation
Southampton R&D
Duration of Study in the UK
8 years, 0 months, 1 days
Research summary
Research Summary
Acute respiratory tract infections are responsible for over 4 million deaths each year and are the third most common cause of death worldwide. Respiratory viruses are the most common detectable pathogen in adults with acute respiratory infection.
Influenza and other respiratory virus infections often remain undiagnosed in patients admitted to critical care due to lack of systematic testing. Even when testing occurs, treatment is often delayed because of slow turnaround times of laboratory methods.
Treatment for influenza in hospitalised adults with neuraminidase inhibitors (e.g. Tamiflu / oseltamivir) is recommended by national guidelines. Prompt treatment with neuraminidase inhibitors reduces the risk of death.
Point-of-care tests (POCT) for respiratory viruses, with antigen detection-based assays, have been limited in clinical practice by unacceptably low sensitivities and by an inadequate range of detectable viruses. Newer molecular systems, such as the FilmArray Respiratory Panel have comparable sensitivity to laboratory tests, detect a wide range of viruses, and can generate a result in about an hour, making them deployable as POCTs.
We propose a single-centre, pilot, randomised controlled trial in adults with acute severe respiratory illness admitted to critical care (respiratory high dependency unit and intensive care units) at University Hospital Southampton NHS Foundation Trust. 300 patients over three years will be recruited and randomised (1:1) to receive either the intervention of a nose and throat swab, immediately tested on the FilmArray Respiratory Panel, or standard clinical care alone. Those allocated to standard clinical care will have a swab taken for later analysis to allow assessment of missed diagnoses. The outcomes assessment will be by retrospective case note analysis. The outcome measures include the proportion of influenza-positive patients appropriately treated with neuraminidase inhibitors, antibiotic use, isolation facility use, length of stay in critical care and length of stay in hospital.
Summary of Results
The new test identified many more bugs responsible for pneumonia (chest infection) than the current standard tests. As a result of this, 80% of patients who had the new test had their antibiotics tailored for the organisms present (compared to 29% of patients who just had standard testing).
Patients who got the new test were more likely to have a 'broadening' of therapy (be given antibiotics which are effective against a wider range of bugs) and also were more likely to have a 'narrowing' of therapy when compared to standard tests.
There was no difference in outcomes like mortality or time in hospital between the new and old tests.REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0110
Date of REC Opinion
24 Mar 2017
REC opinion
Favourable Opinion