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NCT Number: NCT06808451

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

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Diana N Mitchell, MD, MBA, BSN

CONTACT

[email protected]

216-844-1000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in symptoms as measured by UTI-SIQ-8 questionnaire

    Time frame: 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.

  2. Change in symptoms as measured by the UTI Symptom Assessment questionnaire

    Time frame: 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 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

    Time frame: Up to 21 days

    Duration will be measured in days

  4. Number of times participant represents with UTI symptoms as measured by medical record review

    Time frame: Up to 30 days

    Duration will be measured in days

  5. Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review

    Time frame: Up to 21 days

  6. Number of hospitalizations related to UTI as measured by medical record review

    Time frame: Up to 21 days

Study contacts

Contact information is provided by the study sponsor or research team.

Diana N Mitchell, MD, MBA, BSN

CONTACT

[email protected]

216-844-1000

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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