NextGen - Clinical Implication of Next Generation Sequencing

Last updated: December 26, 2024
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

4

Condition

Urinary Tract Infections

Treatment

Next Gen

Antibiotic

Clinical Study ID

NCT05206500
IRB00073565
  • Ages 18-80
  • Female

Study 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 Criteria

Inclusion

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-upvisits

  • Able to give informed consent

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Next Gen
Phase: 4
Study Start date:
May 17, 2022
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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