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

University Hospitals (UH)

Status: Enrolling

Conditions: Urinary Tract Infections

Treatments: Device: DNA PCR; Diagnostic Test: Urine Culture

Study type: Interventional

Funder types: Other

Identifiers

NCT06808451

STUDY20241345

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

DNA Polymerase Chain Reaction (PCR)

Experimental group

Description:

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

Treatment:

Device: DNA PCR

Urine Culture

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Urine Culture