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NextGen - Clinical Implication of Next Generation Sequencing

Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture

Who can join

Ages 18 to 80 · Women

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

About the study

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.

What is being tested

• Antibiotic (drug)
• Next Gen (device)

Sponsor: Wake Forest University Health Sciences · Participants: 100 · Started: May 17, 2022

Contact the study team

• Majid Mirzazadeh, MD · Phone: 336-716-4310
• Sachin N Vyas, MS, PhD · Phone: 336-713-4098

Official record on ClinicalTrials.gov — NCT05206500

Locations in the U.S.

Conditions

• Urinary Tract Infections

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.