Back to search results

NextGen Study for Urinary Tract Infections

This study, called NextGen, is looking at new ways to detect bacteria in urine for women with urinary tract infections (UTIs). It's for women aged 18 to 80 who have UTI symptoms and a low colony count (U/C growth of less than 10,000 Colony-Forming Units). You would receive an FDA-approved antibiotic. Researchers will use Next Generation Sequencing (NGS), a new technology that detects bacteria based on their genetic material, to measure the number of bacteria in your urine at the start of the study and again three weeks after treatment. The goal is to see if NGS can help guide treatment for UTIs when traditional tests don't provide clear answers. The study aims to enroll 100 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with an unspecified phase, planning to enroll 100 participants.
What's involved
You would need to return for all scheduled follow-up visits. Your urine will be tested at the beginning of the study and three weeks after treatment.
Compensation
Not stated in the trial record.
Follow-up
Your urine will be tested at baseline and again at 3 weeks post-treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05206500

NextGen - Clinical Implication of Next Generation Sequencing

Recruiting
PHASE4Ages 18–80InterventionalSupportive care
Wake Forest University Health Sciences
~100 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:AntibioticNext Gen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
Measured over Baseline
+1 more outcome measured

Conditions

Urinary Tract Infections

Explore related trials

Urinary Tract Infection

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Majid Mirzazadeh, MD · PRINCIPAL_INVESTIGATOR · Wake Forest Health Sciences

Who to contact

Majid Mirzazadeh, MD
[email protected]
336-716-4310
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

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

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