Condition category
Urological and Genital Diseases
Date applied
10/09/2013
Date assigned
10/09/2013
Last edited
20/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Urinary tract infections (UTIs) are common infections that can affect the bladder, the kidneys and the tubes connected to them. The aim of this study is to assess a new way of treating UTIs that involves a Point Of Care Test (POCT). The POCT aims to provide clinicians at the point of care (i.e. within the practice) within 24 hours with a diagnosis of bacterial UTI (or not) and information about whether the UTI is resistant to commonly used antibiotics. This study will determine whether using this POCT results in patients taking antibiotics correctly. The effect of using the POCT will also be assessed on antibiotic use, recovery (duration of symptoms and symptom burden), antibiotic resistance, UTI recurrence, hospitalisation, costs, and cost effectiveness.

Who can participate?
Non-pregnant women aged 18 and over with symptoms of a UTI

What does the study involve?
Participants are randomly allocated into two groups. One group receive standard care. The other group have their treatment guided by the POCT test. Participants in the POCT group are asked to provide urine and stool samples at the start of the study and two weeks later, with the urine sample being divided so that half is used for the POCT test and half is sent to be tested in a laboratory. Participants in both groups are asked to fill out a symptom diary each day for 14 days and their medical records are searched for information relevant to UTIs after 3 months. Cost data is also collected.

What are the possible benefits and risks of patients?
Patients are followed up closely by the research team, and provide data that may improve the quality of care for this common infection. Apart from the time and effort taken to provide data and samples, there are few risks to participants.

Where is the study run from?
The study is carried out in primary care research networks in Wales, England, Netherlands and Spain

When is the study starting and how long is it expected to run for?
June 2013 to July 2014

Who is funding the study?
Seventh Framework Programme

Who is the main contact?
Nigel Kirby
kirbyn@cardiff.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Thomas-Jones

ORCID ID

http://orcid.org/0000-0001-7716-2786

Contact details

Centre for Trials Research
College of Biomedical & Life Sciences
Cardiff University
7th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 (0)29 20687520
Thomas-jonese@cardiff.ac.uk

Type

Scientific

Additional contact

Prof Chris Butler

ORCID ID

http://orcid.org/0000-0002-0102-3453

Contact details

Nuffield Department of Primary Health Care Sciences
Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
+44 (0)186 528 9306
christopher.butler@phc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14828

Study information

Scientific title

Point of care testing for urinary tract infection in primary care: Stages 3 & 4 - a randomised controlled trial

Acronym

POETIC Stage 3 and 4

Study hypothesis

The randomised controlled trial (RCT) aims to quantify the costs and effects of an optimised POCT guided diagnostic and treatment regime for symptoms of uncomplicated UTI. 540 adult female patients from the 4 participating countries will be randomised to either the POCT arm or the standard care (SC) arm. Participants randomised to the intervention arm will have their treatment guided by the Flexicult™ POCT. This strategy will be based upon guidelines on the management of uncomplicated UTI in primary care in participating countries, and use of a POCT to guide antibiotic management. Urine and stool samples will be obtained at presentation (baseline) and two weeks later. The primary outcome will be appropriateness of antibiotic prescribing.

Ethics approval

Research Ethics Committee for Wales, 28/02/2013, ref: 12/WA/0394

Study design

Randomised interventional and observational trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

Current interventions as of 12/12/2016:
Intervention arm:
Participants randomised to the experimental intervention arm will have their treatment guided by the Flexicult™ POCT. This POCT is a point of care culture-based approach and involves fresh urine being placed on a special agar plate and the excess urine poured off. The plate is then placed in a simple desktop incubator within the practice, and read approximately 24 hours later. The Flexicult™ system has been used in primary care settings in Denmark for approximately 10 years. POETIC will use new Flexicult™ plates that have been developed by the manufacturer and CE marked (Statens Serum Institut, SSI) to include the antibiotics that are most commonly used in the three participating regions. For patients randomised to the POCT intervention, the result of the test should be available 24 hours after baseline recruitment.

Standard care arm:
Patients randomised to the control arm will receive standard care informed by national guidelines. Clinicians will receive a summary of national guidelines on the management of uncomplicated UTI in primary care (UK, Spain and the Netherlands). Participating clinicians will be provided with the relevant summary for their country, and training in best practice based on their national guidelines. The management of patients who are randomised to the standard care arm will therefore be based upon the management decisions of clinicians who have received training in best practice and a summary of their national guideline(s).

Duration of follow-up was 14-days for patient diary, and medical notes review at 3 months.

Previous interventions:
POCT arm or the standard care (SC) arm.
Flexicult Test, The Intervention is a Flexicult test.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Appropriate antibiotic use, defined as consumption of an antibiotic on day three (or days one or two for fosfomycin) for which a pathogen considered to be causing a UTI isolated in a laboratory was sensitive in vitro, and no antibiotic use by those women who did not have a UTI on laboratory culture

Secondary outcome measures

Added 12/12/2016:
1. Severity of 11 signs and symptoms, rated by clinicians using a scale of zero (normal/not affected) to six (as bad as it could be, at day 14 and 3 months
2. Participant-rated severity of symptoms and antibiotic use, recorded in a patient diary on each of the 14 days
3. How patients are able to cope with and understand their illness, measured using the Patient Enablement Instrument at day 14 and 3 months

Overall trial start date

01/06/2013

Overall trial end date

01/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 18 years and above presenting with suspected uncomplicated urinary tract infection.
2. Presenting with at least one of three key urinary tract symptoms (dysuria, urgency including nocturia, and frequency)
3. Able to provide informed consent and willing to complete a patient diary.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

614 participants (approximately 300 in the UK)

Participant exclusion criteria

Added 12/12/2016:
1. Terminally ill
2. Currently receiving treatment for life-threatening cancer (basal cell carcinoma, for example, excluded)
3. Other severe systemic symptoms, such as high fever, renal angle pain, rigors
4. On long-term antibiotic treatment or have received antibiotics for urinary tract infection within the past four weeks
5. Has had bladder surgery (including cystoscopy) within the past four weeks
6. Known or likely to have significant immune compromise (i.e. known immunodeficiency state, on long-term corticosteroid or chemotherapy treatment, insulin dependent diabetes)
7. Known functional or anatomical abnormalities of the genitourinary tract
8. History of pyelonephritis
9. Known pregnancy
10. Unable to provide a urine sample on the day of first presentation

Recruitment start date

23/07/2013

Recruitment end date

13/08/2014

Locations

Countries of recruitment

Netherlands, Spain, United Kingdom

Trial participating centre

South East Wales Trials Unit
Cardiff
CF14 4YS
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Heath Park
Cardiff
CF14 4XN
United Kingdom

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/

Funders

Funder type

Government

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

The results from the trial have been submitted to a journal and are under review. There will also be a final study report for the funder.

IPD sharing plan
The datasets generated and/or analysed during the current study are available from Professor Chris Butler (christopher.butler@phc.ox.ac.uk) on reasonable request.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25425162

Publication citations

Additional files

Editorial Notes

20/02/2017: Clarification re the registration timing and the comment added 01/12/2016 - The study was initially submitted by the NIHR portfolio to the ISRCTN registry on 03/07/2013, before the recruitment of the first participant which started on 23/07/2013. Due to internal coding errors, the trial details had to be resubmitted from the NIHR portfolio to ISRCTN on 10/09/2013 and the registration was finalised on the same date. There were no changes to the information supplied in the second submission. The registration process was initiated before the recruitment started. 12/12/2016: The following changes were made to the trial record: 1. The target number of participants was changed from 540 to 614 participants (approximately 300 in the UK). 2. Spain and the Netherlands were added to the countries of recruitment. 3. The overall trial end date was changed from 31/07/2014 to 01/11/2015. 01/12/2016: The study was submitted for registration on 03/07/2013 before the recruitment of the first participant. Following this submission, there were no subsequent changes to the information as supplied in the study record. The recruitment started on 23/07/2013, after the trialist applied for registration.