Evaluating UTI Outcomes in at Risk Populations

NCT ID: NCT05385536

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7921 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2024-03-29

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.

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.

Conditions

Urinary Tract Infections; Complicated Urinary Tract Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pathnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dispatch Health

Denver, Colorado, United States

Countries

United States

Other Identifiers

2022-PARS

Identifier Type: -

Identifier Source: org_study_id