NCT05206500PHASE4Recruiting

NextGen - Clinical Implication of Next Generation Sequencing

Wake Forest University Health Sciences

Start Date

5/17/2022

Completion Date

12/1/2028

Summary

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DRUG

Antibiotic

DEVICE

Next Gen

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Conditions

Urinary Tract Infections

Locations

Wake Forest Health Sciences

Winston-Salem, North Carolina 27157

United States