Urine Gene Analysis for Pathogen Detection

Completed

• Conditions: Urinary Tract Infections
• Interventions: Diagnostic Test: Urine PCR testing

• Registration Number: NCT05591911
• Lead Sponsor: David Sheyn

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-24
• Study Start: 2023-06-25
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients over 60 years old presenting with acute urinary tract infection symptoms	Urine PCR testing	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals; 🇺🇸 Cleveland, Ohio, United States