NextGen - Clinical Implication of Next Generation Sequencing

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206500
• Other study ID #: IRB00073565
• Status: Recruiting
• Phase: Phase 4
• Start date: May 17, 2022
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Majid Mirzazadeh, MD
• Phone: 336-716-4310
• Email: mmirzaza[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)	NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria <10,000. Result Measure: NGS CC 100 to 10,000	Baseline
Primary	Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)	NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria <10,000, Result Measure: NGS CC 100 to 10,000	3 Weeks Post-Treatment
Secondary	Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000	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"	Baseline
Secondary	Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000	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"	3 Weeks Post-Treatment