Molecular point-of-care testing for respiratory viruses versus routine clinical care in adults with acute respiratory illness presenting to secondary care: a pragmatic randomised controlled trial protocol (ResPOC)

Nathan J Brendish,Tristan W Clark,Ahalya K Malachira

doi:10.1186/s12879-017-2219-x

Abstract

BackgroundRespiratory viruses are associated with a huge socio-economic burden and are responsible for a large proportion of acute respiratory illness in hospitalised adults. Laboratory PCR is accurate but takes at least 24 h to generate a result to clinicians and antigen-based point-of-care tests (POCT) lack sensitivity. Rapid molecular platforms, such as the FilmArray Respiratory Panel, have equivalent diagnostic accuracy to laboratory PCR and can generate a result in 1 h making them deployable as POCT. Molecular point-of-care testing for respiratory viruses in hospital has the potential to improve the detection rate of respiratory viruses, improve the use of influenza antivirals and reduce unnecessary antibiotic use, but high quality randomised trials with clinically relevant endpoints are needed.MethodsThe ResPOC study is a pragmatic randomised controlled trial of molecular point-of-care testing for respiratory viruses in adults with acute respiratory illness presenting to a large teaching hospital in the United Kingdom. Eligible participants are adults presenting with acute respiratory illness to the emergency department or the acute medicine unit. Participants are allocated 1:1 by internet-based randomisation service to either the intervention of a nose and throat swab analysed immediately on the FilmArray Respiratory Panel as a POCT or receive routine clinical care. The primary outcome is the proportion of patients treated with antibiotics. Secondary outcomes include turnaround time, virus detection, neuraminidase inhibitor use, length of hospital stay and side room use. Analysis of the primary outcome will be by intention-to-treat and all enrolled participants will be included in safety analysis.DiscussionMultiple novel molecular POCT platforms for infections including respiratory viruses have been developed and licensed in the last few years and many more are in development but the evidence base for clinical benefit above standard practice is minimal. This randomised controlled trial aims to close this evidence gap by generating high quality evidence for the clinical impact of molecular POCT for respiratory viruses in secondary care and to act as an exemplar for future studies of molecular POCT for infections. This study has the potential to change practice and improve patient care for patients presenting to hospital with acute respiratory illness.Trial registrationThis study was registered with ISRCTN, number ISRCTN90211642, on 14th January 2015.

Highlights

Respiratory viruses are associated with a huge socio-economic burden and are responsible for a large proportion of acute respiratory illness in hospitalised adults
In adult patients hospitalised with laboratory confirmed influenza, 10–30% are admitted to critical care units and 3– 15% die in hospital [15,16,17] with outcomes being predicted by co-morbidity [17, 18]
Estimates of the burden of influenza virus infection in hospitalised adults have traditionally been based on the incidence of the influenzalike-illness syndrome (ILI, defined as fever of >38 °C and new respiratory symptoms) rather than on laboratory confirmed influenza

Summary

Introduction

Respiratory viruses are associated with a huge socio-economic burden and are responsible for a large proportion of acute respiratory illness in hospitalised adults. Estimates of the burden of influenza virus infection in hospitalised adults have traditionally been based on the incidence of the influenzalike-illness syndrome (ILI, defined as fever of >38 °C and new respiratory symptoms) rather than on laboratory confirmed influenza. In addition to acute respiratory presentations, influenza may present as decompensated cardiovascular disease, collapse or diabetic emergencies [23, 24] For this reason many hospitalised cases of influenza are likely to remain undiagnosed. A recent Canadian study estimated that only around one in 14 ED visits due to influenza virus infection were correctly attributed to influenza [25] It is likely, that the burden of influenza and other respiratory viruses amongst hospitalised adults and its economic impact have been underestimated. In addition to influenza viruses, other respiratory viruses including rhinovirus, respiratory syncytial virus, parainfluenza viruses, human metapneumovirus and coronaviruses, cause acute exacerbations of COPD and asthma as well as other acute respiratory presentations [2], which lead to large numbers of hospitalisations every year and significant burdens upon healthcare systems

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