Observational Study of Patients With Uncomplicated Urinary Tract Infection Treated With Antibiotics or Herbal Medicinal Product
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 398
- 试验地点
- 47
- 主要终点
- number of urinary tract infections
研究概览
简要总结
Observational follow-up study of patients included in the clinical trial REGATTA.
详细描述
A follow-up telephone interview of the participants of the clinical trial REGATTA exploring the occurrence of urinary tract infections, pyelonephritis within a follow-up period of three months after inclusion.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •participants of the clinical trial REGATTA
- •informed consent to participate in the observational study REGATTA II
排除标准
- •no informed consent granted
研究组 & 干预措施
Women treated with the herbal drug Uva Ursi
Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm.
干预措施: Placebo to Fosfomycin (Drug)
Women treated with the herbal drug Uva Ursi
Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm.
干预措施: Arctuvan (Drug)
Women treated with antibiotics
Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the fosfomycin arm.
干预措施: Fosfomycin (Drug)
Women treated with antibiotics
Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the fosfomycin arm.
干预措施: Placebo to Arctuvan (Drug)
结局指标
主要结局
number of urinary tract infections
时间窗: 3 months after inclusion in REGATTA
number of urinary tract infection within 3 months after inclusion in REGATTA
number of pyelonephritis
时间窗: 3 months after inclusion in REGATTA
number of pyelonephritis within 3 months after inclusion in REGATTA
次要结局
未报告次要终点
研究者
Karsten Gavenis
Quality Assurance Staff Unit Clinical Trials
University Medical Center Goettingen