Urine Gene Analysis for Pathogen Detection

Urine Gene Analysis for Pathogen Detection, and Resistance Gene Identification for the Urinary Tract Infection Diagnosis

The objective of this study is the detection, quantification, and resistance gene identification of pathogens by using the urine of patients with urinary tract infection (UTI) symptoms.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Diagnostic test: Urine PCR testing

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female and male patients over 60 years old who admit with acute urinary tract infection symptoms to the ambulatory clinics will be included in this research.

Description

Inclusion Criteria:

• Adult men and women 60 years and older who have urinary tract infection
• Can participate in the informed consent process
• Presenting to the clinic with symptoms of UTI or cystitis with no recent history of UTI within the past 21 days
• Able to provide sufficient urine sample volume via clean catch or catheterization for urinalysis, conventional urine culture, and PCR
• Understand and are willing to comply with the study requirements.
• Sample collection able to be sent out the same day via courier

Exclusion Criteria:

• Individuals under 60 years of age
• Unable to provide informed consent
• Urinary diversion of any type
• Chronic indwelling urinary catheter
• No recent history of UTI within the past 21 days
• No antibiotic therapy within the past 21 days
• No recent therapy with Phenazopyridine

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients over 60 years old presenting with acute urinary tract infection symptoms	Diagnostic test: Urine PCR testing; The urine PCR panel will be performed to evaluate the bacterial growth in the patient's urine who is admitted with acute urinary tract symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in hours from patient presentation to optimal antibiotic prescription	Time in hours from patient presentation to optimal antibiotic prescription will be evaluated both for urine culture and urine PCR panel utilization.	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic costs as measured by prescription records	Antibiotic costs spent for UTI treatment will be calculated.	Up to 30 days
Number of patients with antibiotic change as measured by prescription records	In cases where the UTI cannot be treated with the first antibiotic, other antibiotics used for this purpose will be recorded.	Up to 30 days
Duration of antibiotic usage as measured by prescription records	Antibiotic usage duration will be recorded.	Up to 30 days
Number of any HCP visits for same issue as measured by patients reports/medical records	Any visit to HCP for the same issue will be evaluated	Up to 30 days
Number of hospitalization related to UTI as measured by patients reports/medical records	Hospitalization related to UTI will be recorded.	Up to 30 days
Number of additional diagnostic procedures completed in relation to UTI as measured by patients reports/medical records	Additional diagnostic procedures completed in relation to UTI will be recorded.	Up to 30 days

Collaborators and Investigators

• Sponsor: David Sheyn
• Collaborators: Thermo Fisher Scientific, Inc; Vikor Scientific
• Investigators: Principal Investigator: David Sheyn, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Antibiotics; PCR; Urinary tract infection; Urine culture; Bacteriel growth
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections
• Other Study ID Numbers: STUDY20220767

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes