Next Generation Sequencing for Urinary Tract Infections
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?
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
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment based on Next Generation Sequencing results for UTI with low colony count
Follow-up
Participants are monitored for safety and effectiveness after treatment using King's Questionnaire Outcome
Treatment Details
Interventions
- Antibiotic (Antibiotic)
- Next Gen (NGS Device)
Antibiotic is already approved in Canada for the following indications:
- Bacterial infections
- Appendicitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
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
Wake Forest University Health Sciences
Chief Executive Officer since 2020
BS from University of Illinois, MD from Rush University