Evaluating UTI Diagnosis in Nursing Homes

NCT04815369 | Withdrawn

• 1 other identifier: 2021-PUTINH
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Keywords

Nursing Home; Clostridium difficile; PCR; Long Term Care Facility; Skilled Nursing Facility; National Healthcare Safety Network

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  12 Months

Secondary Outcomes (3)

• 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 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, compared to traditional clinical pathways, will reduce UTI antibiotic collateral effects.

  30 Days

Study Arms (2)

Guidance Clinical Pathway

Facilities 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 to a central point person within the Nursing Home (NH) facility

Traditional Clinical Pathway

Facilities will employ their current standard clinical care practices for suspected UTI, including SUC, 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: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cohort of residents residing in the NH facility during 12 consecutive months.-

You may qualify if:

• Certified skilled nursing facilities (SNF) and nursing homes (NH)
• Nonprofit or for-profit freestanding facility certified by Medicare and Medicaid
• Currently utilizing an EMR system
• Minimum bed size of 100

You may not qualify if:

• Assisted Living Facilities and Residential Care Facilities
• Participation in another UTI trial during the study period

Sponsors & Collaborators

• Pathnostics: lead

Study Sites (1)

Pathnostics

Irvine, California, 92614, 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 Officials

• Dave Baunoch, PhD

  Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: June 7, 2021
• Primary Completion: May 30, 2024
• Study Completion: November 8, 2024
• Last Updated: May 28, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)