Using advanced sequencing to improve treatment for urinary tract infections
Official title: Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture
Run by Wake Forest University Health Sciences · NCT05206500 · Data updated 2026-11-12
This study is testing if new lab techniques can help women with urinary tract infections get better antibiotic treatment, especially when their urine tests show low levels of bacteria.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Status | Recruiting |
| Started | May 17, 2022 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT05206500 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are females aged 18 and older with urinary culture growth of less than 10,000 CFU.
✕Probably not a fit
Patients with a catheter in use or those who have consumed antibiotics in the past two weeks may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the clinical implications of Next Generation Sequencing (NGS) and Polymerase Chain Reaction (PCR) for detecting bacteria in urine samples from patients with urinary tract infections (UTIs). It aims to provide better antibiotic sensitivity testing for women with a urinary culture growth of less than 10,000 Colony-Forming Units (CFU), a group often overlooked in traditional testing methods. By comparing these advanced techniques to standard culture methods, the study seeks to enhance treatment options for patients who currently lack guidance for appropriate antibiotic therapy.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and tailored antibiotic treatments for patients with low-level urinary tract infections.
How similar studies have gone: Other studies have shown promise in using advanced sequencing techniques for bacterial detection, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female at least 18 years of age * U/C (Urinary Culture) growth of \<10,000 Colony-Forming Units (CFU) * Understanding and acceptance of the need to return for all scheduled follow-up visits * Able to give informed consent Exclusion Criteria: * Catheter in use (Foley or suprapubic or intermittent) * Not able to provide clean midstream urine * Antibiotic consumption in the past 2 weeks before signing the consent * Pregnant or Planning to Conceive * Incarcerated
Where it's running
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Wake Forest Health Sciences
Winston-Salem, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Majid Mirzazadeh, MD — Wake Forest Health Sciences
- Study coordinator: Majid Mirzazadeh, MD
- Email: mmirzaza@wakehealth.edu
- Phone: 336-716-4310
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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.