Recruiting

Next Generation Sequencing

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05206500

Conditions

Urinary Tract Infections

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Antibiotic

Next Gen

Study Details

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

Study ID

NCT05206500

Start date

May 17, 2022

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Antibiotic

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

Next Gen

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

Primary outcome measure

  • Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) [ Time Frame: Baseline ]
  • Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) [ Time Frame: 3 Weeks Post-Treatment ]

Central Contacts and Locations

Central contacts

Majid Mirzazadeh, MD

336-716-4310mmirzaza@wakehealth.edu

Sachin N Vyas, MS, PhD

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

Locations

Wake Forest Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Majid Mirzazadeh, MD

336-716-4310mmirzaza@wakehealth.edu

Sachin N Vyas, MS, PhD

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

Principal Investigator:

Majid Mirzazadeh, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-12-08.