Evaluating UTI Outcomes in at Risk Populations (At Risk)

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Complicated Urinary Tract Infection
• Intervention / Treatment: Diagnostic test: Guidance UTI Test

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 7921

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80205
      • Dispatch Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients ≥ 65 years of age seen by healthcare professional for UTI

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Guidance clinical pathway; 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.	Diagnostic test: Guidance UTI Test; Guidance® UTI was designed at Pathnostics a CLIA certified/CAP-accredited lab for use clinically to detect bacterial DNA in the urine via M-PCR and to characterize genotypic/phenotypic antibiotic resistance. Microbes are reported semi-quantitatively as cells per milliliter. In addition to bacterial identification, an antimicrobial susceptibility profile is generated through a patented technique referred to as P-AST (pooled antibiotic susceptibility testing); a high-throughput, broth microdilution spectrophotometric assay applied to a panel of antibiotic agents' array on a microplate to determine the MIC of the polymicrobial culture, if more than organism is present. Guidance® UTI is approved by CLIA for use and therefore is not IUO or RUO. Both components of the Guidance® UTI are analytically validated.
Traditional clinical pathway; 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?

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

Collaborators and Investigators

• Sponsor: Pathnostics

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): March 29, 2024
• Study Completion (Actual): March 29, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: 2022-PARS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No