NextGen - Clinical Implication of Next Generation Sequencing

NCT05206500 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: IRB00073565
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000

  Baseline

• Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000

  3 Weeks Post-Treatment

Study Arms (1)

Symptomatic Patients with low Colony Count

OTHER

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

Drug: Antibiotic; Device: Next Gen

Interventions

Antibiotic DRUG

FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC \>0 and \<10,000

Also known as: Ampicillin/Amoxicillin, Antifolates, Cephalosporins, Clindamycin, Extended spectrum penicillins, Fluoroquinolones, Fosfomycin, Linezolid, Metronidazole, Nitrofurantoin, Penicillins, Tetracyclines

Symptomatic Patients with low Colony Count

Next Gen DEVICE

Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.

Symptomatic Patients with low Colony Count

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Anti-Bacterial Agents; Ampicillin; Amoxicillin; Folic Acid Antagonists; Cephalosporins; Clindamycin; Fluoroquinolones; Fosfomycin; Linezolid; Metronidazole; Nitrofurantoin; Penicillins; Tetracyclines

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Penicillin G; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Thiazines; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; 4-Quinolones; Quinolones; Quinolines; Organophosphonates; Organophosphorus Compounds; Acetamides; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Nitroimidazoles; Nitro Compounds; Imidazoles; Nitrofurans; Furans; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Majid Mirzazadeh, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Majid Mirzazadeh, MD

CONTACT

336-716-4310; mmirzaza@wakehealth.edu

Sachin N Vyas, MS, PhD

CONTACT

336-713-4098; sachin.vyas@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with Urinary Tract Infection (UTI) symptoms and Colony-forming Units (CFU) \<10,000 have clinically significant UTIs. Characterizing the species of bacteria growing in low numbers and treating the patients based on bacterial sensitivity will help in resolving patients' symptoms.

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 25, 2022
• Study Start: May 17, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)