Point-of-care testing for gastrointestinal pathogens (GastroPOC) v1.0
Research type
Research Study
Full title
Randomised controlled trial comparing molecular Point-of-Care testing for gastrointestinal pathogens with standard clinical care, in adults presenting to secondary care with suspected infectious gastroenteritis: a pilot study (GastroPOC Trial).
IRAS ID
208839
Contact name
Tristan Clark
Contact email
Sponsor organisation
R&D, University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study will examine the clinical impact of a rapid, molecular, point-of-care test (POCT) for gastrointestinal pathogens detection (FilmArray Gastrointestinal Panel, BioFire, Salt Lake City, Utah, USA, owned by bioMérieux; CE marked) in patients presenting with acute diarrhoea and/or vomiting, compared to routine clinical care in a pilot randomised controlled trial. Screened, eligible and consented adults with acute diarrhoea and/or vomiting in the Acute Medical Unit, Acute Surgical Unit, Emergency Department and inpatient wards of Southampton General Hospital will be randomised to either have a stool sample (or rectal swab) taken and tested for gastrointestinal pathogens by the POCT, or to routine clinical care alone. The participant will be informed of the result if tested. If an infection is detected, the clinical team responsible for patient care will be informed of the result directly.
The clinical impact of this rapid gastrointestinal infection detection test will assessed by measures including, but not limited to, use of isolation facilities, duration of hospital stay, use of antibiotics, rate of pathogen detection and time to diagnosis.
The study recruitment period will be across at least one year to include the typical peak periods for some pathogens with seasonal incidence such as norovirus and Campylobacter. It is designed as a pilot study to provide data to inform the design of a larger randomised controlled trial and health economic analysis planned for the future.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0515
Date of REC Opinion
9 Jan 2017
REC opinion
Further Information Favourable Opinion