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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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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