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Contact Information:

Prof Gail Hayward
+44 (0)1865 289357
gail.hayward@phc.ox.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Evaluation of new rapid tests for diagnosing urinary tract infections in GP practices
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Evaluation of new rapid tests for diagnosing urinary tract infections in GP practices

Not Recruiting

Open to: Female

Age: Adult

Bristol Oxford Manchester Newcastle upon Tyne Southampton

Medical Conditions

Urinary tract infection

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


A urinary tract infection (UTI) is a painful and potentially dangerous condition and will affect almost half of women at least once in their lifetime. The most common treatment is antibiotics, however, antibiotic-resistant UTIs are rising and this is driven further by inappropriate prescriptions of antibiotics.
Current tests for diagnosing UTIs are slow, inaccurate or both. The current standard of care involves using a combination of symptoms, signs and simple dipstick results to predict which women are most likely to have confirmed infection. Better tests, with results available to guide prescriptions, are required to help clinicians avoid prescribing antibiotics to women who do not need them and prescribe the correct antibiotics to those who do. Rapid diagnostic tests for UTIs and their antibiotic resistance are in production, giving clinicians and patients the power to make immediate appropriate treatment decisions.
This study is testing new devices that, hopefully, will quickly tell a GP whether a patient has a UTI – something which is not currently possible. Some of these new devices may also pinpoint which antibiotics may be best suited to treat the infection. To make sure that the devices give reliable information, the researchers will compare the results with those from established tests that can only be done in a specialised laboratory.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Jun 2023 31 Jul 2024

Publications

2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39890136/ (added 03/02/2025)

Potential participants may present to their GP practice suspecting urinary tract infection (UTI) themselves and may have a urine sample that they take to the GP practice with them. Alternatively, the GP/nurse who they see may suspect that the patient has a UTI. The participant will then be given a Participant Information Sheet (PIS) and questionnaire. This will be presented to them either electronically or on paper. If after reading the PIS the patient is happy to take part, they will sign the Participant Summary Sheet to give consent and they will go on to complete the short questionnaire about their eligibility, information about their sample and their UTI symptoms.
Once the participant has completed the questionnaire either a fresh or previously collected sample can be used as long as they are processed within the timeframe specified by the manufacturer of the diagnostic tests.
Once the participant has given consent, the questionnaire is completed and a urine sample is given, the participant's active involvement is complete. Any part of the sample that is required for clinical care will be separated and used according to the participant's usual care. This may vary according to GP practice's usual practice, as according to guidance this may involve visual inspection, dipstick or sending for local laboratory testing. The remaining sample will be used for the research. The answers to the questionnaire will be checked to ensure eligibility by suitably trained staff at the practice. Once eligibility has been confirmed by a member of the study team, the sample will be used for evaluation of the new tests. Part of the remaining sample will be sent to the Specialist Antimicrobial Chemotherapy Unit run by Public Health Wales which will perform reference standard tests.


Adult patients registered at a GP practice that is taking part in the study can participate if they are biologically female, aged 18 years or above, and are experiencing symptoms of a suspected urinary tract infection for fewer than 7 days.

You can take part if:



You may not be able to take part if:


1. Previously recruited to this study 2. Unable to provide a sample that was taken within the timeframe specified by index test developers3. Unable to understand and complete trial materials in English

Qualitative study:GP practice staff involved in the use of new rapid tests for UTIs unable to give consent to an interview with the research team


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • NIHR CRN: West of England
    Whitefriars Lewins Mead
    Bristol
    BS1 2NT
  • NIHR CRN: Thames Valley and South Midlands
    John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU
  • NIHR CRN: Greater Manchester
    Address 2nd Floor Citylabs Nelson Street
    Manchester
    M13 9NQ
  • NIHR CRN: North East and North Cumbria
    Regent Point Regent Farm Road Gosforth
    Newcastle upon Tyne
    NE3 3HD
  • NIHR CRN: Wessex
    Unit 7 Berrywood Business Village Tollbar Way Hedge End
    Southampton
    SO30 2UN

There will be no immediate benefit to the participant for taking part in this study, however, it is hoped that the results will help inform better diagnosis of UTI and prescribing of antibiotics in the future. There is no risk involved however taking part in the study will take up a small amount of the participant’s time.

Prof Gail Hayward
+44 (0)1865 289357
gail.hayward@phc.ox.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Oxford and funded by NHS England.



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Read full details for Trial ID: ISRCTN80937472

Or CPMS 56150

Last updated 03 February 2025

This page is to help you find out about a research study and if you may be able to take part

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