Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture
Overview
- Phase
- Phase 4
- Intervention
- Antibiotic
- Conditions
- Urinary Tract Infections
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Symptomatic Patients with low Colony Count
Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count \<10,000 to be treated based on Next Generation Sequencing result.
Intervention: Antibiotic
Symptomatic Patients with low Colony Count
Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count \<10,000 to be treated based on Next Generation Sequencing result.
Intervention: Next Gen
Outcomes
Primary Outcomes
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
Time Frame: 3 Weeks Post-Treatment
NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria \<10,000, Result Measure: NGS CC 100 to 10,000
Secondary Outcomes
- Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000(3 Weeks Post-Treatment)