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Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular Point-of-Care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol

Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular Point-of-Care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol
Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular Point-of-Care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol
Background
Influenza infections often remain undiagnosed in patients admitted to hospital due to lack of routine testing. When tested for, the diagnosis and treatment of influenza is often delayed due to the slow turnaround times of centralised laboratory PCR testing. Newer molecular systems, such as the FilmArray Respiratory Panel have comparable accuracy to laboratory PCR testing, and can generate a result in under 1 hour, making them potentially deployable as point-of-care tests (POCTs). High quality evidence for the impact of routine POCT for influenza on clinical outcomes is however, currently lacking. This large pragmatic multicentre randomised controlled trial aims to address this evidence gap.
Methods and analysis
The FluPOC trial is a pragmatic, multi-centre, randomised controlled trial evaluating adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England (PHE). Up to 840 patients will be recruited over up to three influenza seasons, and randomised (1:1) to receive either POCT using the FilmArray Respiratory Panel, or routine clinical care. Clinical and infection control teams will be informed of the results in real time and where influenza is detected clinical teams will be encouraged to offered neuraminidase inhibitor (NAI) treatment in accordance with national guidelines. 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 detected and appropriately treated with NAIs, isolation facility use, antibiotic use, length of hospital stay, complications and mortality.
2044-6055
Beard, Kate
85604fec-3541-48cb-9abf-a76c2a32c3f1
Brendish, Nathan J.
d07b588f-4919-456d-8604-04efde7711fd
Malachira, Ahalya K
c4df54f3-faca-4abb-b360-6555048c18f3
Mills, Samuel
bf3525fe-f39a-4896-8ee3-5b60ad704b6f
Chan, Cathleen
7dee73d4-6074-4f28-bb2a-43c33b3f51db
Poole, Stephen
440d7904-ab72-469c-892b-c910cd1cb19b
Clark, Tristan
712ec18e-613c-45df-a013-c8a22834e14f
Beard, Kate
85604fec-3541-48cb-9abf-a76c2a32c3f1
Brendish, Nathan J.
d07b588f-4919-456d-8604-04efde7711fd
Malachira, Ahalya K
c4df54f3-faca-4abb-b360-6555048c18f3
Mills, Samuel
bf3525fe-f39a-4896-8ee3-5b60ad704b6f
Chan, Cathleen
7dee73d4-6074-4f28-bb2a-43c33b3f51db
Poole, Stephen
440d7904-ab72-469c-892b-c910cd1cb19b
Clark, Tristan
712ec18e-613c-45df-a013-c8a22834e14f

Beard, Kate, Brendish, Nathan J., Malachira, Ahalya K, Mills, Samuel, Chan, Cathleen, Poole, Stephen and Clark, Tristan (2019) Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular Point-of-Care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol. BMJ Open. (In Press)

Record type: Article

Abstract

Background
Influenza infections often remain undiagnosed in patients admitted to hospital due to lack of routine testing. When tested for, the diagnosis and treatment of influenza is often delayed due to the slow turnaround times of centralised laboratory PCR testing. Newer molecular systems, such as the FilmArray Respiratory Panel have comparable accuracy to laboratory PCR testing, and can generate a result in under 1 hour, making them potentially deployable as point-of-care tests (POCTs). High quality evidence for the impact of routine POCT for influenza on clinical outcomes is however, currently lacking. This large pragmatic multicentre randomised controlled trial aims to address this evidence gap.
Methods and analysis
The FluPOC trial is a pragmatic, multi-centre, randomised controlled trial evaluating adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England (PHE). Up to 840 patients will be recruited over up to three influenza seasons, and randomised (1:1) to receive either POCT using the FilmArray Respiratory Panel, or routine clinical care. Clinical and infection control teams will be informed of the results in real time and where influenza is detected clinical teams will be encouraged to offered neuraminidase inhibitor (NAI) treatment in accordance with national guidelines. 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 detected and appropriately treated with NAIs, isolation facility use, antibiotic use, length of hospital stay, complications and mortality.

Text
FluPOC Protocol R1 main document clean - Accepted Manuscript
Restricted to Repository staff only until 21 January 2020.
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More information

Accepted/In Press date: 21 October 2019

Identifiers

Local EPrints ID: 435271
URI: https://eprints.soton.ac.uk/id/eprint/435271
ISSN: 2044-6055
PURE UUID: 968c8c1c-0698-4b20-8b80-6cbaf7e27160
ORCID for Nathan J. Brendish: ORCID iD orcid.org/0000-0002-9589-4937
ORCID for Tristan Clark: ORCID iD orcid.org/0000-0001-6026-5295

Catalogue record

Date deposited: 29 Oct 2019 17:30
Last modified: 29 Nov 2019 01:31

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Contributors

Author: Kate Beard
Author: Nathan J. Brendish ORCID iD
Author: Ahalya K Malachira
Author: Samuel Mills
Author: Cathleen Chan
Author: Stephen Poole
Author: Tristan Clark ORCID iD

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