Next Generation Sequencing for Urinary Tract Infections
What You Need to Know Before You Apply
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.
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.12345
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.56789
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.510111213
Who Is on the Research Team?
Majid Mirzazadeh, MD
Principal Investigator
Wake Forest Health Sciences
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Antibiotic
- Next Gen
Antibiotic is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor