NextGen - Clinical Implication of Next Generation Sequencing

Phase 4

Recruiting

• Conditions: Urinary Tract Infections
• Interventions: Drug: Antibiotic; Device: Next Gen

• Registration Number: NCT05206500
• Lead Sponsor: Wake Forest University Health Sciences

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.

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.

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Study Start: 2022-05-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Symptomatic Patients with low Colony Count	Antibiotic	Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count \<10,000 to be treated based on Next Generation Sequencing result.
Symptomatic Patients with low Colony Count	Next Gen	Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count \<10,000 to be treated based on Next Generation Sequencing result.

Primary Outcome Measures

Name	Time	Method
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)	3 Weeks Post-Treatment	NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria \<10,000, Result Measure: NGS CC 100 to 10,000

Secondary Outcome Measures

Name	Time	Method
Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000	3 Weeks Post-Treatment	NGS result focused antibiotic treatment and symptom outcome with the measurement of King's Questionnaire Outcome. Result Measure: Mild, Moderate, and Severe UTI symptoms in last 12 and 24 hours on 7 questions with no symptoms as "0", Mild as "1", Moderate as "2", and Severe as "3"

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States