DNA PCR versus urine culture to diagnose and treat urinary tract infections
Official title: Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial
Run by University Hospitals Cleveland Medical Center · NCT06808451 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 136 (estimated) |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | October 22, 2025 |
| Main results expected | May 30, 2027 |
| Study ends | May 30, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06808451 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.