Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Antibiotic (Drug)
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.
干预措施: Next Gen (Device)
结局指标
主要结局
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
时间窗: 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
次要结局
- Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000(3 Weeks Post-Treatment)