NCT05091931

Diagnosis, Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting

A Prospective Observational Cohort Study Comparing the Effects of Guidance® UTI vs. Culture-based Testing Methods on Antibiotic Prescribing Practices in an Outpatient Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,308 (actual)
• Sponsor: Pathnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Timeline

• Start date: 2022-03-28
• Primary completion: 2024-09-19
• Completion: 2024-09-19
• First posted: 2021-10-25
• Last updated: 2025-05-28

Locations

2 sites across 1 country: United States