POETIC: Point Of carE Testing for urinary tract Infection in primary Care: Study Stages 3 & 4: Randomised controlled trial and post-RCT observational study

Completed

Conditions: cystitis
lower UTI
uncomplicated UTI (urinary tract infection)
10004018
10046590

Registration Number: NL-OMON39651

Lead Sponsor: Cardiff University, contact person Prof. Christopher Butler

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 135

Inclusion Criteria

Female adult patients age 18 years and above presenting to primary care with at least one of three key urinary tract symptoms (dysuria, urgency including noctural, and frequency) and where the clinician suspects uncomplicated UTI. Patients should be able to provide written informed consent.

Exclusion Criteria

Women with one or more of the following are not eligible for inclusion:
* Terminally ill
* Currently receiving treatment for life-threatening cancer (basal cell carcinoma, for example, excluded)
* Other severe systemic symptoms
* On long-term antibiotic treatment or have received antibiotics for urinary tract infection within the past four weeks
* Has had bladder surgery (including cystoscopy) within the past four weeks
* Known or likely to have significant immune compromise (i.e. known immunodeficiency state, on long-term corticosteroid or chemotherapy treatment, insulin dependent diabetes)
* Known functional or anatomical abnormalities of the genitourinary tract
* History of pyelonephritis
* Known pregnancy
* 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
<p>The primary outcome will be appropriate antibiotic use on day 3 (with day 1<br /><br>being the day that the patient consulted with their primary care clinician).<br /><br>For women who do not have a UTI, appropriate antibiotic use on day 3 will be<br /><br>defined as no antibiotic use on this day.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are to compare intervention arms with regard to:<br /><br>* Antibiotic choice in relation to presence of infection and organism<br /><br>susceptibility and antibiotic spectrum<br /><br>* Dose and duration of antibiotic prescribed<br /><br>* Proportion of patients receiving antibiotic prescription<br /><br>* Adherence to national prescribing guidelines<br /><br>* Symptoms / recovery<br /><br>* Recurrence of UTI (within a three month period)<br /><br>* Patient satisfaction with management<br /><br>* Antibiotic resistance in urine and stool samples at two week follow up<br /><br>* Direct / indirect costs<br /><br>* Cost effectiveness </p><br>