Using advanced sequencing to improve treatment for urinary tract infections
Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture
PHASE4 · Wake Forest University Health Sciences · NCT05206500
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05206500 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 and older with urinary culture growth of less than 10,000 CFU.
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.
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 performed: Other studies have shown promise in using advanced sequencing techniques for bacterial detection, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Winston-Salem, North Carolina
- 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
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.
Conditions: Urinary Tract Infections