Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture
Who is this study for? Patients with Urinary Tract Infections
What treatments are being studied? Antibiotic+Next Gen
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Recently more advanced techniques, including Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) are available to detect bacteria in urine based on bacterial genomes. Comparing to traditional culture, these techniques have more sensitivity and could potentially be of a great help in patients with Colony Count of less than 10,000 and more than zero.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
North Carolina
Wake Forest Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Majid Mirzazadeh, MD
mmirzaza@wakehealth.edu
336-716-4310
Backup
Sachin N Vyas, MS, PhD
svyas@wakehealth.ed
336-713-4098
Time Frame
Start Date: 2022-05-17
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
Other: Symptomatic Patients with low Colony Count
Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count \<10,000 to be treated based on Next Generation Sequencing result.
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences