Evaluating UTI Outcomes in at Risk Populations

Study Overview
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Brief Summary
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This is a multicenter, observational comparative cohort, study to evaluate the UTI related adverse event rates between Guidance® UTI clinical pathway versus the current traditional clinical pathways for urine testing.

Detailed Description
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Clinical sites will be identified by an internal database, prepared by the sponsor, based on previous experience with the sites. Study allocation will based on their current usage of Guidance® UTI and the reporting pathway (described above) will be implemented. Those who currently routinely use Guidance® UTI testing procedures will be over sampled 2:1 over those who do not routinely use Guidance® UTI. Larger clinical care systems with multiple care sites may have locations allocated to different cohort. The basis for cohort allocation will be based on the availability and willingness of providers in these markets to implement infrastructure for collecting and reporting of Guidance® UTI clinical pathway. The comparative cluster cohort will be selected from select geographies within the U.S. based on size of general population served matching to those enrolled in the Guidance® UTI clinical pathway. The method of patient care and management (e.g., test ordering and antimicrobial initiation) is at the discretion of the treating physicians. Specimens collected for suspected UTI may be sent to Pathnostics for standard bacterial identification and sensitivities. Guidance® UTI can only be performed at Pathnostics, whereas urine cultures may be performed at any lab. Trained and experienced clinical lab scientists at Pathnostics are always available to assist the ordering provider with results interpretation or any other questions on the report they may have.

Official Title
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Evaluating UTI Outcomes in at Risk Populations

Conditions
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Urinary Tract Infections, Complicated Urinary Tract Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Male or female participants ≥ 65 years of age, no predetermined quotas or ratios for gender participation. High suspicion of active UTI Ability to provide/obtain a clean catch or sterile urine specimen Willing to adhere to follow-up schedule as stated in schedule of events Permanent residence in the same state in which they were consented for the study Able to provide informed consent Exclusion Participation in another UTI trial during the study period Patients in hospice-care or limited life expectancy of ≤1 month) Inability to provide informed consent and/or respond independently to follow up surveys If the provider deems that a urine culture or Guidance UTI is not necessary in clinical management

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Guidance clinical pathway<br>Sites will be provided a standardized infrastructure and process for collecting and reporting of urine test results including unique lab requisitions that contain the option to order Guidance® UTI, Standard Urine Culture (SUC), and Urine Analysis (UA) along with a protocol for results notification. | |
| Traditional clinical pathway<br>Sites will employ their current standard clinical care practices for suspected UTI, including Standard Urine Culture (SUC), Urine Analysis (UA), and Guidance® UTI testing as per current reporting practices. Providers at these facilities will have the option to order any diagnostic test they deem appropriate. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTI-related ED visit and/or hospitalization within 30 days of index visit | UTI-related ED visit and/or hospitalization within 30 days of index visit | within 30 days of index visit | 
| Composite of adverse events associated with index UTI event | Composite of adverse events associated with index UTI event Allergic reactions to antibiotic therapy Progression to pyelonephritis Nausea/vomiting, headache, skin rash, anaphylaxis/hypersensitivity reaction yeast infection (Vaginitis/vulvovaginal candidiasis) Progression to acute renal failure Tendinopathy (including tendon rupture) C. difficile infection Sepsis | within 30 days of index visit | 
| Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription) within 30 days. | Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription) within 30 days. | within 30 days of index visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of empirical antibiotic starts for UTI indication | Rate of empirical antibiotic starts for UTI indication | within 1 year of index visit | 
| Rate of antimicrobial changes for UTI indication | Rate of antimicrobial changes for UTI indication | within 1 year of index visit | 
| Recurrent UTI within 1 year of index visit suspected UTI as measured by total antibiotics prescribed. | Recurrent UTI within 1 year of index visit suspected UTI as measured by total antibiotics prescribed. | within 1 year of index visit | 
| UTI-related ED visit and/or hospitalization within 1 year of index visit | UTI-related ED visit and/or hospitalization within 1 year of index visit | within 1 year of index visit |