An interventional study of DNA PCR and Urine Culture in Urinary Tract Infections, sponsored by University Hospitals Cleveland Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Diagnostic
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.
753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.
This study's planned enrollment of 136 is close to the median of 130 across 524 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.
Device: DNA PCR
Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.
Diagnostic Test: Urine Culture
Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.
Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.
Change in symptoms as measured by UTI-SIQ-8 questionnaire
The UTI-SIQ-8 is an eight item questionnaire that asks about symptom severity and symptom impairment on a likert scale from 0 to 4, 0 being not at all and 4 being very strong/very severe.
Time frame: Baseline, one day after antibiotic completion
Change in symptoms as measured by the UTI Symptom Assessment questionnaire
The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms.
Time frame: Baseline, one day after antibiotic completion
Length of time from patient presentation to initiation of treatment as measured by medical record review
Time frame: Up to 21 days
Number of antibiotic changes as measured by medical record review
Time frame: Up to 21 days
Duration of antibiotic use as measured by medical record review
Duration will be measured in days
Time frame: Up to 21 days
Number of times participant represents with UTI symptoms as measured by medical record review
Duration will be measured in days
Time frame: Up to 30 days
Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review
Time frame: Up to 21 days
Number of hospitalizations related to UTI as measured by medical record review
Time frame: Up to 21 days
Plan to share: No
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University Hospitals Cleveland Medical Center