NCT05206500 NextGen - Clinical Implication of Next Generation Sequencing
| NCT ID | NCT05206500 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Urinary Tract Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-05-17 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2022-05-17 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Majid Mirzazadeh, MD
PRINCIPAL INVESTIGATOR
Wake Forest Health Sciences
Frequently Asked Questions
Who can join the NCT05206500 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05206500 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05206500 currently recruiting?
Yes, NCT05206500 is actively recruiting participants. Contact the research team at mmirzaza@wakehealth.edu for enrollment information.
Where is the NCT05206500 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT05206500 clinical trial?
NCT05206500 is sponsored by Wake Forest University Health Sciences. The principal investigator is Majid Mirzazadeh, MD at Wake Forest Health Sciences. The trial plans to enroll 100 participants.