Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change in symptoms as measured by UTI-SIQ-8 questionnaire
研究概览
简要总结
Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women 18 years and older
- •Presenting to clinic with symptoms of UTI or cystitis
- •Patients with Medicare and Medicaid insurance
排除标准
- •Urinary diversion of any type
- •Chronic indwelling urinary catheter
- •Diagnosed UTI within the previous 21 days
- •Antibiotic therapy within the previous 21 days
- •Use of phenazopyridine within the previous 21 days
- •Commercial insurance
- •Non-English speaking
- •Pregnant patients
研究组 & 干预措施
DNA Polymerase Chain Reaction (PCR)
Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.
干预措施: DNA PCR (Device)
Urine Culture
Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.
干预措施: Urine Culture (Diagnostic Test)
结局指标
主要结局
Change in symptoms as measured by UTI-SIQ-8 questionnaire
时间窗: Baseline, one day after antibiotic completion
The UTI-SIQ-8 is an eight item questionnaire that asks about symptom severity and symptom impairment on a likert scale from 0 to 4, 0 being not at all and 4 being very strong/very severe.
Change in symptoms as measured by the UTI Symptom Assessment questionnaire
时间窗: Baseline, one day after antibiotic completion
The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms.
次要结局
- Length of time from patient presentation to initiation of treatment as measured by medical record review(Up to 21 days)
- Number of antibiotic changes as measured by medical record review(Up to 21 days)
- Duration of antibiotic use as measured by medical record review(Up to 21 days)
- Number of times participant represents with UTI symptoms as measured by medical record review(Up to 30 days)
- Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review(Up to 21 days)
- Number of hospitalizations related to UTI as measured by medical record review(Up to 21 days)
研究者
David Sheyn
Director, Division of Urogynecology and Reconstructive Pelvic Surgery
University Hospitals Cleveland Medical Center