RecruitingNot ApplicableNCT06808451

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


Sponsor

University Hospitals Cleveland Medical Center

Enrollment

136 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Adult men and women 18 years and older
  • Presenting to clinic with symptoms of UTI or cystitis
  • Patients with Medicare and Medicaid insurance

Exclusion Criteria8

  • Urinary diversion of any type
  • Chronic indwelling urinary catheter
  • Diagnosed UTI within the previous 21 days
  • Antibiotic therapy within the previous 21 days
  • Use of phenazopyridine within the previous 21 days
  • Commercial insurance
  • Non-English speaking
  • Pregnant patients

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Interventions

DEVICEDNA PCR

Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.

DIAGNOSTIC_TESTUrine Culture

Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.


Locations(1)

University Hospitals

Cleveland, Ohio, United States

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NCT06808451


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