Specialty: General Practice, Primary sub-specialty: General Practice
Conditions
Interventions
Following consent, participants will complete a short questionnaire collecting basic information, including age, ethnicity, UTI symptoms, relevant medical history, sexual orientation, geographic locat
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Antibiotic use is measured as the proportion of participants receiving an antibiotic prescription for UTI within 28 days post-randomisation, captured via the baseline clinician CRF, patient diaries, Day 7 and Day 28 follow-up calls, and medical notes review. 2. Symptom recovery is measured as the proportion of participants who self-report in the online symptom diary/follow up call as being fully recovered, or recovered with only a slight problem or better, on Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to recovery measured using participant self-reported data from the online symptom diary over 28 days, including full recovery by Day 7, number of days with moderately bad or worse symptoms, and symptom worsening or progression. 2. Antibiotic consumption for UTI measured as the proportion of participants who self-report, via the symptom diary, having taken antibiotics for their UTI during the 28-day trial period. 3. Antibiotic prescription for UTI at the initial appointment measured using data recorded in the clinician baseline form at Day 0. 4. Recurrence of symptoms measured using participant self-reported data from the online symptom diary over 28 days. 5. Microbiologically confirmed occurrence measured using data recorded in the notes review form for the 28-day trial period. 6. Antibiotic side effects measured as proportion of participants who self-report side effects via the symptom diary over the 28-day trial period. 7. Self-reported consumption of over the counter medications for UTI symptoms measured via the online symptom diary over the 28 day trial period. 8. Number of healthcare contacts with UTI symptoms and UTI-related hospitalisation measured via the online symptom diary over the 28 day trial period and data recorded in the notes review. 9. Test performance of the PA-100 measured via the data recorded in the baseline forms on Day 0 including complete test failure, failure of antibiotic susceptibility. 10. Adherence to test result and prescribing measured by data recorded in the baseline forms on day 0 as well as patient adherence with prescribing decision as measured in the online symptom diary over the 28 day trial period. 11. Diagnostic accuracy is assessed by comparing results from the PA-100 test with laboratory urine culture, measured on Day 0. 12. Clinician experience is measured using interviews and consultation observations on Day 0. 13. Patient experience is measured using interviews carried out during the 28 day trial-period, and c | — |
Countries
United Kingdom
Contacts
Public ContactRebecca Lowe
Outcome results
None listed