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

Not Applicable

Not yet recruiting

• Conditions: Urinary Tract Infections

• Registration Number: NCT06808451
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-02-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Study Start: 2025-05-01
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in symptoms as measured by UTI-SIQ-8 questionnaire	Baseline, one day after antibiotic completion	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.
Change in symptoms as measured by the UTI Symptom Assessment questionnaire	Baseline, one day after antibiotic completion	The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms.

Secondary Outcome Measures

Name	Time	Method
Length of time from patient presentation to initiation of treatment as measured by medical record review	Up to 21 days
Number of antibiotic changes as measured by medical record review	Up to 21 days
Duration of antibiotic use as measured by medical record review	Up to 21 days	Duration will be measured in days
Number of times participant represents with UTI symptoms as measured by medical record review	Up to 30 days	Duration will be measured in days
Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review	Up to 21 days
Number of hospitalizations related to UTI as measured by medical record review	Up to 21 days

Trial Locations

Locations (1)

University Hospitals; 🇺🇸 Cleveland, Ohio, United States