Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult men and women 18 years and older
• Presenting to clinic with symptoms of UTI or cystitis
• Patients with Medicare and Medicaid insurance
Locations
United States
Ohio
University Hospitals
RECRUITING
Cleveland
Contact Information
Primary
Diana N Mitchell, MD, MBA, BSN
diana.mitchell@uhhospitals.org
216-844-1000
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 136
Treatments
Experimental: DNA Polymerase Chain Reaction (PCR)
Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.
Active_comparator: Urine Culture
Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.
Related Therapeutic Areas
Sponsors
Leads: University Hospitals Cleveland Medical Center