This prospective, multicenter, comparative cohort observational study is to determine if Guidance® UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy, adverse events, and improves therapeutic accuracy of treatment
We propose to conduct a multicenter, comparative cohort observational study to determine whether the use of Guidance® UTI Clinical Pathway compared with current traditional pathways for urine testing reduces the rates of empiric antibiotic therapy and improves therapeutic accuracy of treatment. Comparative outpatient Urology and urogynecology office cohorts will be allocated at an uneven 2:1 allocation ratio. Regardless of arm assignment, all outpatient offices have the option to order ANY diagnostic test for suspected UTI, this includes urine cultures and/or other molecular testing methods including Guidance® UTI. If a provider in the Guidance Clinical Pathway arm decides to order urine cultures instead of using the Guidance® UTI Clinical Pathway, those results will also be reported to the site lead, though TAT may take up to 72 hours to result per standard culture protocols. We will be observing the practice's implementation of the Clinical Pathway and reporting infrastructure to provide rapid, centralized reporting to the ordering provider, allowing for efficient treatment. Guidance® UTI is currently widely available, and all participating outpatient offices (regardless of arm) will have the option to order this test.
Study Type
OBSERVATIONAL
Enrollment
3,308
First Urology
Louisville, Kentucky, United States
Comprehensive Urology
Royal Oak, Michigan, United States
The percentage of outpatients seen for suspected UTI started on empiric treatment
The percentage of outpatients seen for suspected UTI started on empiric treatment
Time frame: 30 days
Rate of Adverse Events through 30 days
The incidence rate of the adverse events (listed below) 30 days following index visit. * Allergic reactions to antibiotic therapy * Nausea/vomiting, headache, skin rash, anaphylaxis/hypersensitivity reaction * yeast infection (Vaginitis/vulvovaginal candidiasis) * Acute renal failure * tendinopathy (including tendon rupture) * C. difficile infection * ED Visit/Urgent care (UTI) * Hospitalization (UTI) * Sepsis * Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription). All subjects having reported initial resolution of their UTI symptoms by day 14 will be assessed for this outcome.
Time frame: 30 days
Resolution of the Initial UTI Symptoms by Day 14
Patients will be asked about UTI symptoms on days 1- 14 after index visit. Patients showing improvement in overall symptom score over 14 days versus baseline score. Subjects with persistent UTI symptoms or having received further antimicrobials because of UTI symptoms will be considered to have not met the outcome, whereas those without persistent UTI symptoms and not having received further antimicrobials will be considered to have met the outcome.
Time frame: 14 Days
Resolution of Symptoms
Complete Resolution of symptoms by day 30
Time frame: 30 days
Antibiotics Concordance with Sensitivity Results
Percentage of prescribed antibiotics that are concordant with sensitivity results
Time frame: 30 days
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Biomarkers
Number of samples containing biomarker concentration above specific thresholds; unique to each biomarker.
Time frame: 30 days