NCT05591911已完成不适用
Urine Gene Analysis for Pathogen Detection, and Resistance Gene Identification for the Urinary Tract Infection Diagnosis
David Sheyn1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年6月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Time in hours from patient presentation to optimal antibiotic prescription
研究概览
简要总结
The objective of this study is the detection, quantification, and resistance gene identification of pathogens by using the urine of patients with urinary tract infection (UTI) symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women 60 years and older who have urinary tract infection
- •Can participate in the informed consent process
- •Presenting to the clinic with symptoms of UTI or cystitis with no recent history of UTI within the past 21 days
- •Able to provide sufficient urine sample volume via clean catch or catheterization for urinalysis, conventional urine culture, and PCR
- •Understand and are willing to comply with the study requirements.
- •Sample collection able to be sent out the same day via courier
排除标准
- •Individuals under 60 years of age
- •Unable to provide informed consent
- •Urinary diversion of any type
- •Chronic indwelling urinary catheter
- •No recent history of UTI within the past 21 days
- •No antibiotic therapy within the past 21 days
- •No recent therapy with Phenazopyridine
结局指标
主要结局
Time in hours from patient presentation to optimal antibiotic prescription
时间窗: Up to 30 days
Time in hours from patient presentation to optimal antibiotic prescription will be evaluated both for urine culture and urine PCR panel utilization.
次要结局
- Number of patients with antibiotic change as measured by prescription records(Up to 30 days)
- Number of hospitalization related to UTI as measured by patients reports/medical records(Up to 30 days)
- Number of additional diagnostic procedures completed in relation to UTI as measured by patients reports/medical records(Up to 30 days)
- Antibiotic costs as measured by prescription records(Up to 30 days)
- Number of any HCP visits for same issue as measured by patients reports/medical records(Up to 30 days)
- Duration of antibiotic usage as measured by prescription records(Up to 30 days)
研究者
David Sheyn
Associate Professor
University Hospitals Cleveland Medical Center
研究点 (1)
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