NextGen - Clinical Implication of Next Generation Sequencing

Recruiting now · Phase 4

Conditions studied: Urinary Tract Infections

In brief

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.

Key facts

Study ID

NCT05206500

Run by

Wake Forest University Health Sciences

People needed

100

Starts

2022-05-17

Expected to finish

2028-12-01

Last updated by the study team

2025-12-08

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Wake Forest Health Sciences — Winston-Salem, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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