NCT05206500

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Bacterial sensitivity test for different antibiotics are the most important guide for treatment of patients with UTI. Unfortunately, for patients with less than 10,000 Colony Count (CC), usually no sensitivity test is done and there is not any guide for appropriate antibiotic therapy for this group.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Antibiotic	FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC \>0 and \<10,000
DEVICE	Next Gen	Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.

Timeline

• Start date: 2022-05-17
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2022-01-25
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study