DNA PCR versus urine culture to diagnose and treat urinary tract infections
Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial
This study will test whether a DNA PCR test instead of a standard urine culture gives faster or more useful results for adults who come to clinic with UTI symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06808451 on ClinicalTrials.gov |
What this trial studies
Adults aged 18 and older who present to a clinic with symptoms of urinary tract infection are randomized to either standard urine culture or a DNA PCR testing pathway. At enrollment participants complete two questionnaires and, if prescribed antibiotics, they are contacted the day after their scheduled antibiotic stop date and asked to complete follow-up questionnaires. The study procedures and follow-up last up to 21 days. Key exclusions include urinary diversion, chronic indwelling catheter, recent antibiotic use, pregnancy, non-English speakers, and patients with commercial insurance.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults (18+) who present to the University Hospitals clinic with UTI or cystitis symptoms and have Medicare or Medicaid insurance.
Not a fit: Patients with urinary diversions, chronic indwelling catheters, recent antibiotic use, commercial insurance, non-English speakers, or pregnant patients are excluded and would not receive benefit from participation.
Why it matters
Potential benefit: If successful, this approach could provide faster and more accurate identification of the bacteria causing UTIs, allowing timelier and more targeted treatment.
How similar studies have performed: Molecular tests like PCR have shown quicker detection and higher sensitivity than culture in research settings, but they have not yet replaced urine culture as routine care.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- University Hospitals — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: David Sheyn, MD — University Hospitals
- Study coordinator: Diana N Mitchell, MD, MBA, BSN
- Email: diana.mitchell@uhhospitals.org
- Phone: 216-844-1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.