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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult men and women 18 years and older

Presenting to clinic with symptoms of UTI or cystitis

Patients with Medicare and Medicaid insurance

Disqualifiers

Urinary diversion of any type

Chronic indwelling urinary catheter

Diagnosed UTI within the previous 21 days

Antibiotic therapy within the previous 21 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: DNA Polymerase Chain Reaction (PCR)Experimental treatment 1 intervention
Group B: Urine CultureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

Length of time from patient presentation to initiation of treatment as measured by medical record review

Time frame
Up to 21 days
2

Number of antibiotic changes as measured by medical record review

Time frame
Up to 21 days
3

Duration of antibiotic use as measured by medical record review

Duration will be measured in days

Time frame
Up to 21 days
4

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

Other outcomes

Sponsors and contacts

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