Evaluating UTI Diagnosis in Nursing Homes

Withdrawn

• Conditions: Urinary Tract Infections

• Registration Number: NCT04815369
• Lead Sponsor: Pathnostics

Brief Summary

This prospective, multicenter, comparative cohort observational study is to determine whether the use of Guidance® UTI Clinical Pathway, a standardized infrastructure for specimen collection and result delivery, compared with current traditional pathways for urine testing reduces the proportion of UTI patients with poor outcomes.

Detailed Description

The objective of this study is to determine if prospective data, collected over 12 months from over 200 nursing homes, will show that the use of Guidance® UTI Clinical Pathway is more effective than the Traditional Clinical Pathways for urine testing in UTI diagnosis in Nursing Homes. Guidance® UTI Clinical Pathway provides standardized infrastructure for specimen collection, and result dissemination via assigned report point person to verify receipt of actionable data. The pathway also includes several in-services on molecular testing for UTI, Pooled Antibiotic Susceptibility Testing, and polymicrobial infections to help providers better understand test methodology. Standardizing a Clinical Care Pathway for testing and reporting of clinical results approach may lead to a reduction in empiric broad spectrum antibiotic use and in turn better health-related outcomes for patients. Such efficiency in clinical decision making at the time of initial presentation may lead to improved patient care by avoiding ineffective therapy due to mismanagement or incomplete lab diagnosis. The study will be observing the implementation of the Guidance® UTI Clinical Pathway and comparing it to traditional clinical care pathways from facility-level data entered into the National Healthcare Safety Network for its LTCF (Long Term Care Facilities) Component.

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-25
• Study Start: 2021-06-07
• Primary Completion: 2024-05-30
• Status Verified: 2024-11
• Study Completion: 2024-11-08
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce the proportion of patients with UTI-related adverse events.	12 Months	Examine the proportion of patients with UTI-related adverse events requiring emergency hospital services over the course the study with a composite measure of the number of UTI related ED visits and/or subsequent hospitalizations and/or sepsis events.

Secondary Outcome Measures

Name	Time	Method
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce overall inappropriate antibiotic use.	30 Days	Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce overall inappropriate antibiotic use as measured by the rate of empiric antibiotic starts and the rate of antimicrobial changes for UTI indication.
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway is more effective than standard urine testing approaches in the clinical evaluation of UTI diagnosis and management .	12 Months	Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway is more effective than standard urine testing approaches in the clinical evaluation of UTI diagnosis and management as measured by UTI incidence and corresponding urine testing rate; * (UTI and Catheter associated (CA)-UTI bacterial identification incidence rates (diagnostic aim); * Population UTI Rate = (UTI Episodes/Resident Days) x 1,000; * CA-UTI Rate = (CA-UTI Episode/Catheter days) x 1,000
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce UTI antibiotic collateral effects.	30 Days	Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce UTI antibiotic collateral effects as measured by: * C. diff event rate = (Total C. diff events/ total resident days) x 1,000

Trial Locations

Locations (1)

Pathnostics; 🇺🇸 Irvine, California, United States