Urine Gene Analysis for Pathogen Detection

David Sheyn

Status: Completed

Conditions: Urinary Tract Infections

Treatments: Diagnostic Test: Urine PCR testing

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05591911

STUDY20220767

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

96 participants in 1 patient group

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

Treatment:

Diagnostic Test: Urine PCR testing