~35 spots leftby Dec 2026

Next Generation Sequencing for Urinary Tract Infections

Recruiting in Palo Alto (17 mi)
MM
Overseen byMajid Mirzazadeh, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Wake Forest University Health Sciences
Must not be taking: Antibiotics
Disqualifiers: Catheter use, Pregnancy, Incarceration, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial requires that you have not taken antibiotics in the past 2 weeks before signing the consent. Other medications are not mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Next Generation Sequencing for Urinary Tract Infections?

The research highlights that new antibiotics, which are part of the treatment, are essential for treating UTIs, especially those caused by multidrug-resistant bacteria. Additionally, the use of broad-spectrum antibiotics, which are included in the treatment, is effective for complicated UTIs.12345

Is Next Generation Sequencing for Urinary Tract Infections safe for humans?

The safety of antibiotics used for urinary tract infections has been studied, with some new antibiotics showing low rates of side effects like nausea and dizziness. In studies, cinoxacin, a type of antibiotic, had fewer side effects compared to other common treatments, suggesting that these treatments are generally safe for humans.16789

How is the drug used in the clinical trial for urinary tract infections different from other treatments?

The drug in the clinical trial uses next-generation sequencing (NGS) to more accurately identify the bacteria causing the infection, allowing for a more targeted antibiotic choice. This approach is unique because it increases the sensitivity of detecting urinary pathogens, potentially leading to more effective treatment compared to traditional methods that may not account for specific bacterial resistance patterns.110111213

Research Team

MM

Majid Mirzazadeh, MD

Principal Investigator

Wake Forest Health Sciences

Eligibility Criteria

This trial is for women aged 18 to 80 with a urinary tract infection (UTI) that's hard to detect using standard tests. They must be able to consent, follow the study schedule, and have low levels of bacteria in their urine. It's not for those who use catheters, can't give a clean urine sample, are pregnant or trying to conceive, incarcerated, or took antibiotics recently.

Inclusion Criteria

I am a woman aged between 18 and 80.
Able to give informed consent
You have a low amount of bacteria in your urine.
See 1 more

Exclusion Criteria

I have not taken antibiotics in the last 2 weeks.
You have a catheter in place.
You cannot provide a clean sample of urine collected midstream.
See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment based on Next Generation Sequencing results for UTI with low colony count

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment using King's Questionnaire Outcome

3 weeks

Treatment Details

Interventions

  • Antibiotic (Antibiotic)
  • Next Gen (NGS Device)
Trial OverviewThe trial is testing how well advanced DNA techniques like PCR and Next Generation Sequencing can identify UTI-causing bacteria compared to traditional methods. These new tests could be more sensitive for detecting low-level infections in patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Symptomatic Patients with low Colony CountExperimental Treatment2 Interventions
Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count \<10,000 to be treated based on Next Generation Sequencing result.

Antibiotic is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Antibiotics for:
  • Bacterial infections
  • Appendicitis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+
Dr. L. Ebony Boulware profile image

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag profile image

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Findings from Research

For simple urinary tract infections caused by drug-sensitive bacteria, low-cost antibiotics like trimethoprim-sulfamethoxazole or nitrofurantoin are effective and should be preferred due to their low morbidity and cost.
In cases of complicated urinary tract infections, it's crucial to perform diagnostic studies and base antibiotic choices on culture results, with broad-spectrum agents like fluoroquinolones being effective options with low expected morbidity.
Antimicrobial agents in urinary tract infections in patients with spinal cord injury.Carson, CC.[2005]
Escherichia coli is the primary cause of uncomplicated urinary tract infections (UTIs), while complicated UTIs involve a wider range of bacteria, including multiresistant strains, necessitating more complex treatment strategies.
Current antibiotic therapies face challenges due to rising antibiotic resistance, prompting the need for strategies such as optimizing dosing, reducing antibiotic use, and developing new treatments to effectively manage UTIs.
Treatment of bacterial urinary tract infections: presence and future.Wagenlehner, FM., Naber, KG.[2022]
There has been a notable increase in severe urinary tract infections (UTIs), highlighting the need for new antibiotics, especially due to the rise of multidrug-resistant bacteria that can lead to serious complications like urosepsis.
Recent research has focused on developing patient-centered evaluation strategies for clinical studies, which aim to better assess the effectiveness of new antibiotics against traditional treatments for UTIs.
[Urinary tract infections including pyelonephritis].Wagenlehner, FME.[2023]

References

Antimicrobial agents in urinary tract infections in patients with spinal cord injury. [2005]
Treatment of bacterial urinary tract infections: presence and future. [2022]
[Urinary tract infections including pyelonephritis]. [2023]
Emerging drugs for bacterial urinary tract infections. [2007]
[Therapy of lower urinary tract infections in children]. [2006]
Novel Antibiotics in the Treatment of Urinary Tract Infections. [2019]
Cinoxacin: mechanism of action, spectrum of activity, pharmacokinetics, adverse reactions, and therapeutic indications. [2019]
Review of adverse reactions associated with cinoxacin and other drugs used to treat urinary tract infections. [2019]
The microbiological and pharmacokinetic profile of an antibacterial agent useful for the single-dose therapy of urinary tract infection. [2019]
Comparative Effectiveness Randomized Clinical Trial Using Next-generation Microbial Sequencing to Direct Prophylactic Antibiotic Choice Before Urologic Stone Lithotripsy Using an Interprofessional Model. [2023]
Useful agents in the management of urinary tract infections. [2019]
Antimicrobial Treatment Options for Difficult-to-Treat Resistant Gram-Negative Bacteria Causing Cystitis, Pyelonephritis, and Prostatitis: A Narrative Review. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Urinary tract infections. [2018]