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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39651
Enrollment
135
Registered
2013-10-09
Start date
2014-02-18
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cystitis lower UTI uncomplicated UTI (urinary tract infection)

Interventions

Participants in stage 3 will be randomised (ratio 1:1) to receive the POCT management strategy or the standard care (SC) treatment. Participants randomised to the intervention arm will have their tr

Sponsors

Cardiff University, contact person Prof. Christopher Butler
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary outcome will be appropriate antibiotic use on day 3 (with day 1 being the day that the patient consulted with their primary care clinician). For women who do not have a UTI, appropriate antibiotic use on day 3 will be defined as no antibiotic use on this day.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)