Evaluating UTI Outcomes in at Risk Populations

NCT05385536 | Completed

• 1 other identifier: 2022-PARS
• Study Type: observational
• Target: 7,921
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infections; Complicated Urinary Tract Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Rate of empirical antibiotic starts for UTI indication

  within 1 year of index visit

• 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.

  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

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pathnostics: lead

Study Sites (1)

Dispatch Health

Denver, Colorado, 80205, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 23, 2022
• Study Start: July 18, 2022
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)