RecruitingPhase 4NCT05206500

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


Sponsor

Wake Forest University Health Sciences

Enrollment

100 participants

Start Date

May 17, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAntibiotic

FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC \>0 and \<10,000

DEVICENext 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05206500


Related Trials