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

Abstract

Background: single-occupancy isolation rooms are a limited resource in UK hospitals but are critical 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 hour but their clinical impact is unknown.
Methods: in this pragmatic, randomised controlled trial, we enrolled adults hospitalised with suspected gastroenteritis in a large UK hospital. Patients were randomly allocated (1:1) to receive syndromic molecular point-of-care testing (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. Secondary outcomes included the time to results, time to de-isolation, antibiotic use, and safety outcomes. The study was registered (ISRCTN88918395) and is complete.
Findings: between March 20, 2017 and March 17, 2020, 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 to 2∙2) in the mPOCT group compared with 2∙6 (2∙2 to 3∙0) days 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 hours (1∙5 to 2∙0) for mPOCT and 44∙7 hours (21∙2 to 66∙1) for the control group (p<0∙0001). Time to de-isolation was 0·6 days (0·3 to 1·8) in the mPOCT group compared with 2·2 days (1·2 to 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 in length of stay, re-admission, or mortality between groups.
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.

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Identifiers

ORCID for Nathan Brendish: orcid.org/0000-0002-9589-4937

ORCID for Tristan Clark: orcid.org/0000-0001-6026-5295

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