NCT06808451

Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture

Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DEVICE	DNA PCR	Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.
DIAGNOSTIC_TEST	Urine Culture	Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.

Timeline

• Start date: 2025-10-22
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-02-05
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study