Urinary Tract InfectionsPhase 4NCT05206500
NextGen - Clinical Implication of Next Generation Sequencing
A Phase 4 study testing Antibiotic and Next Gen in people with Urinary Tract Infections, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Antibiotic and Next Gen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2022to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
Majid Mirzazadeh, MD, 336-716-4310, mmirzaza@wakehealth.edu
Sachin N Vyas, MS, PhD, 336-713-4098, sachin.vyas@advocatehealth.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Antibiotic, Next Gen
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
Also called Ampicillin/Amoxicillin, Antifolates, Cephalosporins, Clindamycin
FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC >0 and <10,000
Next GenDevice
Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Antibiotic; Device: Next Gen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 Weeks Post-Treatment
Secondary outcomes (2)
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"
Measured: 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"
Measured: 3 Weeks Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start17 May 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Majid Mirzazadeh, MD, Principal investigator, Wake Forest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206500
- Sponsor's protocol ID
- IRB00073565
- Status last verified
- Dec 2025
- First submitted
- 7 Jan 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual Participant Data are not planned to be shared. All subject related information will be available under the subject ID.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture
- ClinicalTrials.gov ID
- NCT05206500
- Acronym / sponsor ID
- IRB00073565
- Conditions
- Urinary Tract Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Patients with low Colony Count | Other | Drug: Antibiotic, Device: Next GenPatients with positive urinalysis, symptomatic, and Urine Culture Colony Count <10,000 to be treated based on Next Generation Sequencing result. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticAlso: Ampicillin/Amoxicillin, Antifolates, Cephalosporins, ClindamycinFDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC >0 and <10,000 | Drug | Symptomatic Patients with low Colony Count |
| Next GenNext Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes. | Device | Symptomatic Patients with low Colony Count |
Primary outcome
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
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
2 secondary outcomes
Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000
Time frame: Baseline
Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000
Time frame: 3 Weeks Post-Treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No. Individual Participant Data are not planned to be shared. All subject related information will be available under the subject ID.
Related trials for Urinary Tract Infections
Active, not recruiting
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
Active, not recruitingObservational study
The Impact of De-implementing Urine Dipsticks for Diagnosis of UTIs in Hospitals
Urinary Tract Infections, Diagnostic Techniques and Procedures
RecruitingPhase 3
Precision Management of Urinary Tract Symptoms in Older Women
Urinary Tract Infection (Diagnosis)
Enrolling by invitation
VA Quality Enhancement Research Initiative (QUERI) CARRIAGE VAST
Common Infections, Urinary Tract Infections
Not yet recruitingPhase 3
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
Kidney Transplant Infection, Bloodstream Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Majid Mirzazadeh, MD principal investigator
Wake Forest Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic and Next Gen in people with Urinary Tract Infections, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Majid Mirzazadeh, MD (336-716-4310, mmirzaza@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.