Evaluation of new rapid tests for diagnosing urinary tract infections in GP practices

Not Applicable

• Conditions: rinary tract infection; Urological and Genital Diseases

• Registration Number: ISRCTN80937472
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-07
• Last Update Posted: 3 October 2023
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

1. Female
2. Aged 18 years or above
3. Presenting to UK Primary Care with current symptoms that have been present for fewer than 7 days, that the patient or their primary care health professional think are consistent with an uncomplicated UTI
4. Clinician confirms that urine sample for analysis is useful for patient’s care
5. Participant is willing to give consent for participation in the study

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

Exclusion Criteria

1. Previously recruited to this study
2. Unable to provide a sample that was taken within the timeframe specified by index test developers
3. 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The diagnostic performance of novel point-of-care tests for diagnosing urinary tract infection against standard laboratory testing as the reference standard, measured at baseline

Secondary Outcome Measures

Name	Time	Method
1. The symptoms of people who seek help from their GP with suspected UTIs, measured via participant questionnaire completed at baseline<br>2. Whether and how using the results of a new point-of-care test would result in a change in antibiotic prescribing, measured via the record of prescriptions issued and urine samples collected at the time of consultation (baseline)<br>3. How often the new tests go wrong and how frequently they give uninterpretable results, measured at baseline