EVOLUTION: EValuating a nOveL UTI diagnOstic for aNtibiotic stewardship
Specialty: General Practice, Primary sub-specialty: General Practice; Health Category: Infection; Disease/Condition: Other diseases of urinary system
Following consent, participants will complete a short questionnaire collecting basic information, including age, ethnicity, UTI symptoms, relevant medical history, sexual orientation, geographic location, and any allergies to UTI antibiotics. Suitably trained staff at the GP practice, pharmacy, or other primary care provider will assess eligibility. If eligible, participants will be randomly assigned to either the usual diagnostic process or the diagnostic process with the PA-100 test (test-guided care group). All participants must provide a urine sample on the same day and will receive a leaflet advising on self-care for their UTI. Participants in the usual diagnostic process will be treated and diagnosed according to standard care, which may involve visual inspection, dipstick testing, or local laboratory testing, depending on local processes. Participants in the test-guided care group will have their urine sample processed using the PA-100 device within 30 minutes of sample collection. Clinicians may use the PA-100 results to diagnose and treat the UTI. Once the test is complete, the clinician will contact the participant to discuss their treatment. All participants will have a proportion of their urine sample sent to the Specialist Antimicrobial Chemotherapy Unit, Public Health Wales, for reference standard tests. Follow-up will involve participants receiving a daily link via text or email to complete a web-based symptom diary for the first 14 days, followed by weekly entries until day 28. If any entries are missed, the trial team or site team will contact participants by phone between days 7–12 and 28–36 to provide assistance. Routine health record data will be collected by site staff for up to 28 days after randomisation. For the qualitative component, some clinicians and participants may be invited to take part in an optional interview, conducted by telephone, online (for example via Microsoft Teams), or in person, to share their experience of participati
1. Assigned Female at birth 2. Aged >= 18 years or above. 3. New presentation of symptoms, which the primary care clinician considers consistent with a suspected uncomplicated UTI. 4. Willing and able to comply with study procedures, including the need to provide a urine specimen within the correct timeframe and has access to email. 5. Willing and able to give informed consent for participation in the study. Qualitative: 1. Individuals from the participating site qualified to prescribe antibiotics including doctors, nurses, paramedics and pharmacists 2. Other staff from the participating site involved in delivering the PA-100 test (e.g. healthcare assistants) 3. Willing and able to comply with study procedures 4. Willing and able to give informed consent for the interview 5. Participants willing to give consent to an interview with the research team. 6. Clinicians from recruiting sites and participants willing to give consent for their consultation to be audio or video recorded.
An individual may not enter the trial if ANY of the following apply: 1. Pregnancy. In cases where it is possible that a patient is pregnant but unaware of it, a pregnancy test will be performed as usual care. However, since this risk assessment is conducted in usual care and in the majority of cases the risk will be low, we have not made a negative pregnancy test a requirement for study entry. 2. On long-term antibiotic treatment 3. Antibiotics taken for UTI in the preceding 7 days or prior treatment with antibiotics for the current UTI episode. 4. Known structural or functional urinary tract abnormalities (e.g. neuromuscular conditions, surgical). 5. Terminal illness 6. Indwelling or intermittent catheterisation 7. Care home resident 8. Previous recruitment to the EVOLUTION trial 9. Immunocompromise due to a relevant condition or due to immunosuppressive therapy. 10. Renal disease 11. Diabetes Qualitative: 1. Staff not directly involved in antibiotic prescribing or delivering the PA-100 test 2. Staff who decline or are unable to provide informed consent 3. Clinicians from recruiting sites and participants not willing to give consent for their consultation to be audio or video recorded.