A Prospective Observational Cohort Study Comparing the Effects of Guidance® UTI vs. Culture-based Testing Methods on Antibiotic Prescribing Practices in an Outpatient Setting
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Tract Infections
- Sponsor
- Pathnostics
- Enrollment
- 3308
- Locations
- 2
- Primary Endpoint
- The percentage of outpatients seen for suspected UTI started on empiric treatment
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to provide verbal informed consent
- •Male and Female Subjects \> 18 years of age may participate with no predetermined quotas or ratios for gender participation (Group 2).
- •Male and Female Subjects \> 18 and older may participate with no predetermined quotas or ratios for gender participation (Group 1).
- •A history of complicated UTI (cUTI)\*\*
- •Must present at the time of enrollment with clinically suspected active UTI (any LUTS)
- •Management requires microbial identification and sensitivities of urine
- •\*\*Definition of cUTI- A UTI is considered complicated when the individual has one or more risk factors that predispose to higher treatment failure and poor outcomes.6 These poor outcomes include persistence of UTI, increasing severity, or occurrence of complications such as urosepsis, recurrence, and perinephric abscess. Although the definition of cUTI may vary among current medical bodies and organizations, for this study, we define examples of cUTIs to include:
- •UTIs in the elderly population due to increased chances of comorbidities and immune compromised state,
- •Recurrent UTIs2, which is defined as the occurrence of ⩾2 symptomatic episodes within 6 months or ⩾3 symptomatic episodes within 12 months
- •UTI in patients with anatomic or functional pathology affecting the urinary tract, such as an obstruction, hydronephrosis, renal tract calculi, or colovesical fistula
Exclusion Criteria
- •Patients with history of chronic pelvic pain syndrome/interstitial cystitis (Excluded in GROUP 2 only)
- •Patients that are receiving radiation therapy in the pelvic region
- •Patients with history of unstable, untreated, or are failing treatment for overactive bladder (either neurogenic or non-neurogenic)
- •Patients with history of bladder malignancy in the past 3 years
- •Patients that have been treated with chemotherapy in the past 3 years
- •Inability to independently provide symptom data
- •Patient must have email access if they choose to complete surveys online.
- •Pregnancy
- •Incarceration
Outcomes
Primary Outcomes
The percentage of outpatients seen for suspected UTI started on empiric treatment
Time Frame: 30 days
The percentage of outpatients seen for suspected UTI started on empiric treatment
Rate of Adverse Events through 30 days
Time Frame: 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.
Secondary Outcomes
- Resolution of the Initial UTI Symptoms by Day 14(14 Days)
- Biomarkers(30 days)
- Resolution of Symptoms(30 days)
- Antibiotics Concordance with Sensitivity Results(30 days)