Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DNA PCR, Urine Culture.
- Who it may be relevant to
- Registry conditions: Urinary Tract Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial
Overview
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.
Interventions
- Device DNA PCR
Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms. - Diagnostic test Urine Culture
Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.
Primary outcome measures
- Change in symptoms as measured by UTI-SIQ-8 questionnaire [Time frame: Baseline, one day after antibiotic completion]
- Change in symptoms as measured by the UTI Symptom Assessment questionnaire [Time frame: Baseline, one day after antibiotic completion]
Secondary outcome measures (6)
- 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 [Time frame: Up to 21 days]
- Number of times participant represents with UTI symptoms as measured by medical record review [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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University Hospitals — Cleveland
Identifiers
NCT: NCT06808451 · STUDY20241345