Actively Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial
Led by University Hospitals Cleveland Medical Center · Updated on 2026-03-11
136
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating diagnostic methods for adults 18 years or older with symptoms of urinary tract infection (UTI). This randomized trial compares DNA Polymerase Chain Reaction (PCR) gene analysis to routine urine culture to diagnose and guide treatment for acute UTI. The study aims to understand how these two methods affect symptom changes and treatment timelines. Participants are randomly assigned to one of two groups: the DNA PCR group, where gene analysis is performed on urine samples, or the urine culture group, where samples undergo routine culture testing at the hospital lab. At enrollment, participants complete two questionnaires about their symptoms. If antibiotics are prescribed, participants will be contacted the day after finishing treatment to complete follow-up questionnaires. The study participation lasts up to 21 days. During the study, researchers collect symptom assessments at baseline and after antibiotic completion using specific questionnaires. Medical records are reviewed to track treatment timing, antibiotic use, changes in therapy, repeat UTI symptoms, additional diagnostic procedures, and hospitalizations related to UTI. This comprehensive monitoring helps measure the impact of each diagnostic approach on patient outcomes and care within the study period.
CONDITIONS
Brief Title
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women 18 years and older
- Presenting to clinic with symptoms of UTI or cystitis
- Patients with Medicare and Medicaid insurance
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days
Participants provide urine samples for gene analysis using DNA PCR or routine urine culture to diagnose urinary tract infection.
1 visit (in-person)
Duration - Up to 30 days
Participants are monitored for changes in symptoms, antibiotic use, and any recurrence of urinary tract infection symptoms after diagnosis.
Follow-up assessments up to 30 days after diagnosis
Trial Site Locations
Total: 1 location
1
University Hospitals
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
D
Diana N Mitchell, MD, MBA, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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