Urine Gene Analysis for Pathogen Detection

NCT05591911 | Completed

• 1 other identifier: STUDY20220767
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infections

Keywords

Urinary tract infection; Urine culture; Bacteriel growth; Antibiotics; PCR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Antibiotic costs as measured by prescription records

  Up to 30 days

• Number of patients with antibiotic change as measured by prescription records

  Up to 30 days

• Duration of antibiotic usage as measured by prescription records

  Up to 30 days

• Number of any HCP visits for same issue as measured by patients reports/medical records

  Up to 30 days

• Number of hospitalization related to UTI as measured by patients reports/medical records

  Up to 30 days

Study Arms (1)

Patients over 60 years old presenting with acute urinary tract infection symptoms

Diagnostic Test: Urine PCR testing

Interventions

Urine PCR testing DIAGNOSTIC_TEST

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.

Patients over 60 years old presenting with acute urinary tract infection symptoms

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Sheyn: lead
• Vikor Scientific: collaborator
• Thermo Fisher Scientific, Inc: collaborator

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, 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

• David Sheyn, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: June 25, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)