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NCT Number: NCT05206500

NextGen - Clinical Implication of Next Generation Sequencing

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.

Recruiting

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic

Drug

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

Other names: Ampicillin/Amoxicillin, Antifolates, Cephalosporins, Clindamycin, Extended spectrum penicillins, Fluoroquinolones, Fosfomycin, Linezolid, Metronidazole, Nitrofurantoin, Penicillins, Tetracyclines

Next Gen

Device

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

Primary outcomes

  1. Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)

    Time frame: Baseline

    NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria <10,000. Result Measure: NGS CC 100 to 10,000

  2. Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)

    Time frame: 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 outcomes

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

    Time frame: Baseline

    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"

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

    Time frame: 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"

Study contacts

Contact information is provided by the study sponsor or research team.

Majid Mirzazadeh, MD

CONTACT

[email protected]

336-716-4310

Sachin N Vyas, MS, PhD

CONTACT

[email protected]

336-713-4098

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jan 25, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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