Recruiting

Urine Culture & DNA PCR

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT06808451

Conditions

Urinary Tract Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DNA PCR

Urine Culture

Study Details

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.

Conditions

Urinary Tract Infections

Study ID

NCT06808451

Start date

Oct 22, 2025

Status verified date

Mar, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: DNA Polymerase Chain Reaction (PCR)

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

active comparator: Urine Culture

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

Interventions

DNA PCR

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

Urine Culture

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Diana N Mitchell, MD, MBA, BSN

216-844-1000diana.mitchell@uhhospitals.org

Locations

University Hospitals

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Diana N Mitchell, MD, MBA, BSN

216-844-1000diana.mitchell@uhhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • urine culture
  • DNA PCR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-03-11.