NextGen - Clinical Implication of Next Generation Sequencing
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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 design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Majid Mirzazadeh, MD; Sachin N Vyas, MS, PhD
Data sourced from clinicaltrials.gov
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