Point of care testing for urinary tract infection in primary care: Stages 3 & 4

Not Applicable

Completed

• Conditions: Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases; Urological and Genital Diseases; Urinary tract infection, site not specified

• Registration Number: ISRCTN65200697
• Lead Sponsor: Cardiff University (UK)

Brief Summary

1. 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25425162 2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29483078 (added 24/01/2019) 3. 2019 results in https://pubmed.ncbi.nlm.nih.gov/31873085/ (added 11/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-10
• Study Completion: 2015-11-01
• Last Update Posted: 24 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 614

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> Added 12/12/2016:<br> 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<br> 2. Participant-rated severity of symptoms and antibiotic use, recorded in a patient diary on each of the 14 days<br> 3. How patients are able to cope with and understand their illness, measured using the Patient Enablement Instrument at day 14 and 3 months<br>