Clinical impact of syndromic molecular point-of-care testing for gastrointestinal pathogens in adults hospitalised with suspected gastroenteritis (GastroPOC): a pragmatic, open-label, randomised controlled trial.

Autor:	Brendish NJ; School of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; NIHR Southampton Biomedical Research Centre and Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK. Electronic address: n.brendish@soton.ac.uk., Beard KR; School of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; NIHR Southampton Biomedical Research Centre and Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Malachira AK; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Tanner AR; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Sanga-Nyirongo L; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Gwiggner M; Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Cummings JRF; School of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; NIHR Southampton Biomedical Research Centre and Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Moyses HE; NIHR Southampton Biomedical Research Centre and Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Clark TW; School of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; NIHR Southampton Biomedical Research Centre and Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK; University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Jazyk:	angličtina
Zdroj:	The Lancet. Infectious diseases [Lancet Infect Dis] 2023 Aug; Vol. 23 (8), pp. 945-955. Date of Electronic Publication: 2023 Apr 25.
DOI:	10.1016/S1473-3099(23)00066-X
Abstrakt:	Background: Single-occupancy isolation rooms are a finite resource in UK hospitals but are crucial in preventing transmission of infection. Patients with suspected gastroenteritis are nursed in single-occupancy rooms, but delays in laboratory testing lead to non-infectious patients remaining isolated for prolonged periods unnecessarily. Rapid molecular test panels for gastrointestinal pathogens have a run time of around 1 h but their clinical impact is unknown. We aimed to evaluate the clinical impact of syndromic molecular point-of-care testing (mPOCT) for gastrointestinal pathogens in adult patients presenting to hospital with suspected gastroenteritis on single-occupancy room use and a range of other outcome measures. Methods: In this pragmatic, open-label, randomised controlled trial, we enrolled adults hospitalised with suspected gastroenteritis in a large UK hospital. Patients were randomly allocated (1:1) to receive syndromic mPOCT of stool or rectal samples, or to routine clinical care (control) with laboratory testing. The primary outcome was the duration of time in single-occupancy rooms assessed on a modified intention-to-treat basis. Secondary outcomes included the time to results, time to de-isolation, antibiotic use, and safety outcomes. The study was registered with ISRCTN, ISRCTN88918395, and is complete. Findings: Between March 20, 2017 and March 17, 2020, from 455 patients assessed for eligibility, we enrolled 278 patients, 138 assigned to mPOCT (one withdrawal) and 140 to the control group. The duration (geometric mean) of single-occupancy room isolation was 1·8 days (95% CI 1·5-2·2) in the mPOCT group compared with 2·6 days (2·2-3·0) in the control group (exponentiated coefficient 0·70 [95% CI 0·56 to 0·87]; p=0·0017). The median (IQR) time to results was 1·7 h (1·5-2·0) for mPOCT and 44·7 h (21·2-66·1) for the control group (p<0·0001). Time to de-isolation was 0·6 days (0·3-1·8) in the mPOCT group compared with 2·2 days (1·2-3·2) in the control group, (p<0·0001). Antibiotics were given in 89 (65%) of 137 in the mPOCT group and 66 (47%) of 140 in the control group (p=0·0028). There were no differences between groups in length of hospital stay, or in safety outcomes including mortality, intensive care unit admission, or readmission to hospital. Interpretation: mPOCT for gastrointestinal pathogens in patients with suspected gastroenteritis returned results more rapidly than conventional testing and was associated with a reduction in single-occupancy room use. However, these benefits need to be balanced against a potential increase in antibiotic use. Funding: University Hospital Southampton NHS Foundation Trust. Competing Interests: Declaration of interests TWC has received speaker fees, honoraria, travel reimbursement, and equipment and consumables at discount or free of charge for purposes independent of research, outside of this submitted study, from BioFire Diagnostics–bioMérieux and QIAGEN. He has received consultancy fees from BioFire Diagnostics–bioMérieux, Cepheid, Roche, Janssen, Synairgen, Randox Laboratories, IP Pragmatics, and Cidara therapeutics; has received speaker fees or honoraria from Janssen, Sanofi, and Medscape; has received honoraria for participation in advisory boards from Cepheid, Roche, Janssen, Seqirus, Sanofi, and Shionogi; is a member of an independent data monitoring committee for a trial sponsored by Roche; owns Synairgen stock; has acted as the UK chief investigator for a study sponsored by Janssen; was supported by a National Institute for Health Research (NIHR) post-doctoral fellowship (grant number PDF 2016-09-061); has received grant funding via an NIHR AMR research infrastructure award; andhas received grant funding from the Norwegian Research Council for the CAPNOR randomised controlled trial. NJB is supported by the NIHR Clinical Lecturer programme. KRB is supported by the NIHR Academic Clinical Fellow programme. All other authors declare no competing interests. (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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