Urine Gene Analysis for Pathogen Detection

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591911
• Other study ID #: STUDY20220767
• Status: Recruiting
• Start date: June 25, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: David Sheyn, MD
• Phone: 216-844-3009
• Email: David.Sheyn[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
David Sheyn	Thermo Fisher Scientific, Inc, Vikor Scientific

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Antibiotic costs as measured by prescription records	Antibiotic costs spent for UTI treatment will be calculated.	Up to 30 days
Secondary	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
Secondary	Duration of antibiotic usage as measured by prescription records	Antibiotic usage duration will be recorded.	Up to 30 days
Secondary	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
Secondary	Number of hospitalization related to UTI as measured by patients reports/medical records	Hospitalization related to UTI will be recorded.	Up to 30 days
Secondary	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