Condition category
Digestive System
Date applied
20/02/2017
Date assigned
21/02/2017
Last edited
20/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Many adults patient are admitted to hospital with diarrhoea every year. Some of these patients have infections and some have diarrhoea for other reasons. Patients with infections need to be isolated in a side room quickly to stop their infection from spreading to other patients. Some patients with infection will also need specific antibiotic treatment whilst others will not. The current tests that the NHS uses to look for infection in patients with diarrhoea take up to 5 days for a result. This means whilst the test result is awaited all patients with diarrhoea are put in a side room in case they have an infection and doctors have to make an educated guess as to who to treat with antibiotics. There are new tests available that are as accurate as standard laboratory tests and can generate a result in one hour. These are called molecular, point-of-care tests (POCT). The testing device is small and easy to use and so can be used at the patient’s bedside rather than in a laboratory. This means that when a patient comes in with diarrhoea the doctors can know very quickly if they need to be isolated and if they need antibiotics or not. As the test is new there is no information as to whether testing patients like this will improve their care or be cost effective for the NHS. The aim of this study is to find out whether using this new test at patient’s bedsides improves the way they are cared for and the way that side rooms are used in hospital.

Who can participate?
Adult patients in a Southampton General Hospital who have had sudden diarrhoea or vomiting.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have their stools tested immediately using the molecular, point-of-care test (POCT) device. The results are then passed onto the healthcare team so that they can start antibiotic treatment if they need it. A further stool sample is also taken to be stored and tested at a later date. Those in the second group are managed according to standard practices, which involve having stool samples sent to the laboratory for testing. Throughout their hospital stay, patients in both groups have their medical records reviewed in order to find out how long they are kept in isolation in a side room and what care they receive, as well as completing an optional survey about their satisfaction with the care received.

What are the possible benefits and risks of participating?
It is not known whether having the new test will lead to improvements in patient care but it is possible that patients will directly benefit in terms of being cared for in the correct environment and having the antibiotic treatment given or withheld as appropriate. There are no anticipated risks involved with participating.

Where is the study run from?
Southampton General Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2016 to September 2019

Who is funding the study?
Biofire Diagnostics, LLC (UK)

Who is the main contact?
Ms Emma Levell
emma.levell@uhs.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Emma Levell

ORCID ID

Contact details

Southampton General Hospital
Mailpoint 218
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 2381 206832
emma.levell@uhs.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33068

Study information

Scientific 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)

Acronym

GastroPOC

Study hypothesis

The aim of this study is to 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.

Ethics approval

West Midlands - Solihull Research Ethics Committee, 09/01/2017, ref: 16/WM/0515

Study design

Randomised; Interventional; Design type: Diagnosis, Process of Care, Device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Infectious diseases and microbiology, Primary sub-specialty: Other; UKCRC code/ Disease: Infection/ Intestinal infectious diseases

Intervention

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: Participants will have a molecular Point-of-Care test (POCT) performed on stool with the results immediately communicated to the clinical team, infection prevention and control (IPAC) team and the patient. Subsequent clinical management decisions are made independently by the responsible clinical and IPAC teams.

Control group: Participants will be managed according to routine clinical care, where testing for pathogens in stool is at the discretion of the responsible clinical team and where performed will use the standard NHS laboratory testing. A stool sample also will be taken and stored and tested at later date with the POCT to allow direct comparison of the pathogens detected between the groups (i.e. missed diagnoses).

For participants in both groups, clinical and demographic data is collected at enrolment and for outcome measures is collected retrospectively from case notes and electronic hospital information systems. Patient satisfaction surveys are performed immediately prior to discharge. There is no follow up.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 outcome measures

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 pathogen positive patients 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 review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum)
12. Patient satisfaction is measured using a validating NHS survey tool at the point of discharge
13. Safety is measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum)

Overall trial start date

01/09/2016

Overall trial end date

01/09/2019

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant 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.

Recruitment start date

01/03/2017

Recruitment end date

01/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University Hospital Southampton NHS Foundation Trust

Sponsor details

Mailpoint 18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Biofire Diagnostics, LLC

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The findings of this study will be disseminated locally and regionally and will be presented at national and international scientific meetings. The result swill published in high impact peer-reviewed scientific journals.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and may be made available at a later date.

Intention to publish date

01/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes