Point-of-care testing for gastrointestinal pathogens
| ISRCTN | ISRCTN88918395 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88918395 |
| Secondary identifying numbers | 33068 |
- Submission date
- 20/02/2017
- Registration date
- 21/02/2017
- Last edited
- 10/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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 March 2020
Who is funding the study?
Biofire Diagnostics, LLC (UK)
Who is the main contact?
Ms Emma Levell
emma.levell@uhs.nhs.uk
Contact information
Scientific
University of Southampton Faculty of Medicine and University Hospital Southampton NHS Foundation LF101, Level F, South Academic Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2381 290 8410 |
|---|---|
| t.w.clark@soton.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Diagnosis, Process of Care, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN88918395_PIS_26Jan17_V2.1.docx |
| Scientific title | 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) |
| Study acronym | GastroPOC |
| Study objectives | 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(s) | West Midlands - Solihull Research Ethics Committee, 09/01/2017, ref: 16/WM/0515 |
| Health condition(s) or problem(s) studied | Gastroenteritis |
| 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 |
| Primary outcome measure | 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 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 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) Added 21/03/2019: 14. Proportion of pathogen-positive patients de-isolated, measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) 15. Proportion of pathogen-negative patients de-isolated, measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) Added 04/09/2020: Measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days where appropriate): 16. Duration of time in a side room for pathogen positive patients 17. Duration of time in a side room for pathogen negative patients 18. Proportion of pathogen positive patients isolated in a side room 19. Proportion of pathogen negative patients isolated in a side room 20. Proportion of patients with bacterial gastroenteritis treated with antibiotics 21. Proportion of patients without bacterial gastroenteritis treated with antibiotics 22. Other medication use, complications (inc Acute Kidney Injury), ICU admissions, 30-day mortality, representation and readmission Added 28/05/2021: Missed diagnoses measured by retrospective review of case notes and electronic hospital information systems for the duration of hospitalisation (up to 30 days maximum) |
| Overall study start date | 01/09/2016 |
| Completion date | 17/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300 |
| Total final enrolment | 278 |
| Key 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) |
| Key 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. |
| Date of first enrolment | 01/03/2017 |
| Date of final enrolment | 01/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton
SO16 6YD
United Kingdom
Sponsor information
Hospital/treatment centre
Mailpoint 18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
"ROR" |
https://ror.org/0485axj58 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 results will published in high impact peer-reviewed scientific journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Tristan Clark or Dr Nathan Brendish (t.w.clark@soton.ac.uk, n.brendish@soton.ac.uk); data are available upon reasonable request, participants’ data are fully anonymised, and all participants have given written consent for future data use. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2.1 | 26/01/2017 | 21/02/2017 | No | Yes |
| Protocol (other) | 16/06/2021 | 10/10/2022 | No | No | |
| Protocol file | version 2.0 | 30/05/2018 | 10/10/2022 | No | No |
| Results article | 25/04/2023 | 02/05/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN88918395_PIS_26Jan17_V2.1.docx
- Uploaded 21/02/2017
- ISRCTN88918395_Protocol_V2.0_30May2018.pdf
Editorial Notes
10/05/2023: The overall study end date was changed from 01/04/2022 to 17/03/2020. IPD sharing statement added.
02/05/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
10/10/2022: Protocol file uploaded.
03/05/2022: The following changes have been made:
1. The overall trial end date has been changed from 01/03/2021 to 01/04/2022 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 01/09/2021 to 31/12/2022.
28/05/2021: The secondary outcome measures were updated.
04/09/2020: The following changes were made to the trial record:
1. The overall end date was changed from 01/09/2020 to 01/03/2021.
2. The intention to publish date was changed from 01/12/2020 to 01/09/2021.
3. The secondary outcome measures were updated.
4. The plain English summary was updated to reflect these changes.
25/04/2019: Dr Tristan Clark has been added as the scientific contact and Emma Levell's details have been removed.
28/03/2019: The condition has been changed from "Specialty: Infectious diseases and microbiology, Primary sub-specialty: Other; UKCRC code/ Disease: Infection/ Intestinal infectious diseases" to "Gastroenteritis" following a request from the NIHR.
21/03/2019: The following changes were made to the trial record:
1. The scientific title was changed from '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)' to '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)'.
2. The target number of participants was changed from 200 to 300.
3. The recruitment end date was changed from 01/03/2019 to 01/03/2020.
4. The overall trial end date was changed from 01/09/2019 to 01/09/2020.
5. The intention to publish date was changed from 01/12/2019 to 01/12/2020.
6. The secondary outcome measures were updated.
