NextGen - Clinical Implication of Next Generation Sequencing

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Amoxicillin; Ampicillin; Anti-Bacterial Agents; Cephalosporins; Clindamycin; Fluoroquinolones; Fosfomycin; Linezolid; Metronidazole; Nitrofurantoin; Penicillins; Tetracycline

Criteria

Inclusion Criteria:

• Female 18 to 80 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