RECRUITINGPhase 4INTERVENTIONAL
NextGen - Clinical Implication of Next Generation Sequencing
Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture
About 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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Antibiotic
FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC \>0 and \<10,000
DEVICE
Next Gen
Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.
Locations (1)
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States