Skip to content

Point-of-care testing for gastrointestinal pathogens

Randomised controlled trial comparing syndromic molecular point-of-care testing for gastrointestinal pathogens with standard clinical care, in adults presenting to secondary care with suspected infectious gastroenteritis (GastroPOC Trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88918395
Enrollment
300
Registered
2017-02-21
Start date
2017-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteritis Infections and Infestations Other gastroenteritis and colitis of infectious and unspecified origin

Interventions

Participants will be randomised to one of two groups in a 1:1 ratio using an internet-based randomisation service using random permuted blocks of varying sizes (4, 6 and 8). Intervention group: Part

Sponsors

University Hospital Southampton NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Has the capacity to give informed, written consent and is able and willing to adhere to the study procedures 3. A patient in Southampton General Hospital ED, AMU, ASU or inpatient ward (if admitted directly to an inpatient ward) 4. Can be recruited to the study within a 48 hour period of first triage by ED staff OR within a 48 hour period of arrival on AMU or ASU or inpatient ward (if admitted directly to AMU/ASU to these areas) 5. Has an acute diarrhoeal illness and/or vomiting* 5. Has a duration of illness less of than or equal to 14 days *An episode of acute diarrhoea is defined as the passage of at least 3 loose stools for at least 1 day. (AMU = acute medical unit, ASU = acute surgical unit, ED = emergency department)

Exclusion criteria

Exclusion criteria: 1. Patients not fulfilling inclusion criteria 2. A palliative approach being taken by the treating clinicians 3. Previously included in this study and re-presenting within the last 30 days after hospital discharge 4. Declines to give stool sample and/or rectal swab Involvement in other research trials is not necessarily an exclusion criterion. Concurrent, prior or subsequent enrolment in an observational study is not expected to be an exclusion criterion, except at the discretion of the principal investigator.

Design outcomes

Primary

MeasureTime frame
Duration of time in side room isolation is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum)

Secondary

MeasureTime frame
1. Proportion of patients isolated in a side room is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) 2. Time to patient isolation in a side room is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) 3. Time to de-isolation in pathogen negative patients is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) 4. Proportion of patients treated with antibiotics is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) 5. Time to treatment with antibiotics is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) 6. Duration of antibiotics is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) 7. Duration of hospitalisation is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) 8. Proportion of patients with a pathogen detected is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) 9. Time to diagnosis is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) 10. Concordance between results obtained from rectal swab and stool culture is measured retrospectively at a time point >30 days post enrolment by comparing the result of diagnostic testing 11. Turnaround time is measured by retrospective

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026