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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)

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)
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)

BACKGROUND: Respiratory 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.

METHODS: The 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.

DISCUSSION: Multiple 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 REGISTRATION: This study was registered with ISRCTN, number ISRCTN90211642 , on 14th January 2015.

Journal Article
1471-2334
128
Brendish, Nathan J.
d07b588f-4919-456d-8604-04efde7711fd
Malachira, Ahalya
dd1d5b84-f338-44a5-9429-3e3e93a1c953
Clark, Tristan W
712ec18e-613c-45df-a013-c8a22834e14f
Brendish, Nathan J.
d07b588f-4919-456d-8604-04efde7711fd
Malachira, Ahalya
dd1d5b84-f338-44a5-9429-3e3e93a1c953
Clark, Tristan W
712ec18e-613c-45df-a013-c8a22834e14f

Brendish, Nathan J., Malachira, Ahalya and Clark, Tristan W (2017) 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). BMC Infectious Diseases, 17 (1), 128. (doi:10.1186/s12879-017-2219-x).

Record type: Article

Abstract

BACKGROUND: Respiratory 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.

METHODS: The 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.

DISCUSSION: Multiple 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 REGISTRATION: This study was registered with ISRCTN, number ISRCTN90211642 , on 14th January 2015.

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Accepted/In Press date: 24 January 2017
e-pub ahead of print date: 6 February 2017
Published date: 6 February 2017
Keywords: Journal Article

Identifiers

Local EPrints ID: 413743
URI: https://eprints.soton.ac.uk/id/eprint/413743
ISSN: 1471-2334
PURE UUID: ff7554da-d391-4873-be6e-becd5b15f7ba
ORCID for Nathan J. Brendish: ORCID iD orcid.org/0000-0002-9589-4937
ORCID for Tristan W Clark: ORCID iD orcid.org/0000-0001-6026-5295

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Date deposited: 01 Sep 2017 16:32
Last modified: 03 Dec 2019 01:35

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Contributors

Author: Nathan J. Brendish ORCID iD
Author: Ahalya Malachira
Author: Tristan W Clark ORCID iD

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