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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: Antibiotic; Device: Next Gen

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Majid Mirzazadeh, MD; Phone Number: 336-716-4310; Email: mmirzaza@wakehealth.edu
• Study Contact Backup: Name: Sachin N Vyas, MS, PhD; Phone Number: 336-713-4098; Email: svyas@wakehealth.ed

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Health Sciences
      • Contact: Majid Mirzazadeh, MD; Phone Number: 336-716-4310; Email: mmirzaza@wakehealth.edu
      • Contact: Sachin N Vyas, MS, PhD; Phone Number: 336-713-4098; Email: svyas@wakehealth.edu
      • Principal Investigator: Majid Mirzazadeh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Symptomatic Patients with low Colony Count; Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count <10,000 to be treated based on Next Generation Sequencing result.

Drug: Antibiotic; FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC >0 and <10,000; Other Names: Metronidazole; Fluoroquinolones; Clindamycin; Fosfomycin; Linezolid; Ampicillin/Amoxicillin; Antifolates; Cephalosporins; Extended spectrum penicillins; Nitrofurantoin; Penicillins; Tetracyclines; Device: Next Gen; Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Majid Mirzazadeh, MD, Wake Forest Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents, Urinary; Linezolid; Metronidazole; Ampicillin; Anti-Bacterial Agents; Clindamycin; Amoxicillin; Fluoroquinolones; Nitrofurantoin; Tetracycline; Penicillins; Fosfomycin; Cephalosporins
• Other Study ID Numbers: IRB00073565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data are not planned to be shared. All subject related information will be available under the subject ID.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No