跳至主要内容
临床试验/NCT04831840
NCT04831840终止不适用

Is PCR Amplification More Sensitive Than Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Recurrent Bladder Infections?

University of Miami2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
32
试验地点
2
主要终点
Proportion of patients negative for repeat testing

研究概览

简要总结

The primary objective is to determine if polymerase chain reaction (PCR) (UTIP™) is more sensitive in identifying urinary tract infections (UTI's) than standard urine cultures.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 y/o-90 y/o
  • Able to consent
  • Group A only: Recurrent UTI (2 UTIs in 6 months)
  • Group B only: No history of recurrent UTIs

排除标准

  • Pelvic radiation
  • Urinary retention (>200 ml residual)
  • Greater than Stage 2 prolapse
  • Renal calculi
  • Immunosuppressed
  • Neurologic disorder with significant bladder impairment
  • No current UTI via dip stick

结局指标

主要结局

Proportion of patients negative for repeat testing

时间窗: Up to 4 weeks

The proportion of negative patient on repeat testing of urine samples.

Proportion of uropathogens

时间窗: Day 1

The proportion of uropathogens found on PCR versus urine culture from urine samples.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Martin

Assistant Professor

University of Miami

研究点 (2)

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