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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT06808451
Status
Recruiting
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Conditions

  • Urinary Tract Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 22, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Change in symptoms as measured by UTI-SIQ-8 questionnaire [ Time Frame: Baseline, one day after antibiotic completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University HospitalsClevelandOhio44106
Diana N Mitchell, MD, MBA, BSN
[email protected]
216-844-1000

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By research site
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