Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 398
- 试验地点
- 47
- 主要终点
- antibiotic courses
研究概览
简要总结
It is well known that "over-treatment" of straightforward infections should be avoided as far as possible. Evidence-based data on non antibiotic treatment options for common conditions are therefore needed urgently. This randomised-controlled double blind trial examines whether initial herbal treatment with Uva Ursi, and antibiotic treatment only if symptoms persist, reduces antibiotic consumption in uncomplicated urinary tract infections (UTI) without a negative effect on symptom course and rate of recurrent UTIs. In total, 430 patients presenting with typical UTI symptoms will be included by their GPs and receive randomised either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial antibiotic treatment. Patients record symptom severity and drug intake in a diary and complete a final questionnaire after 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Women (18-75 years) with suspected UTI
- •at least two symptoms of UTI (dysuria, urgency of micturition, frequency, lower abdominal pain)
- •Written informed consent
排除标准
- •signs of complicated UTI (e. g. temperature > 38°C, loin tenderness)
- •conditions that may lead to complicated infections (i.e. renal diseases, patients with urinary catheter)
- •pregnancy/ breastfeeding
- •current self-medication with UU preparations e.g. z.B. Cystinol®, Uvalysat®, Arctuvan®
- •antibiotic use in the last 7 days
- •previous UTI in the past 2 weeks
- •history of pyelonephritis
- •contraindications for trial drugs
- •serious diseases
- •inability to understand trial Information
- •current participation in another clinical trial or participation in another clinical trial within the last 4 weeks
研究组 & 干预措施
Uva Ursi
placebo to fosfomycin: 3 g granules orally 1x1 (day 0)
and
Uva Ursi: 105 mg (Arctuvan®) 3x2 tablets orally from day 0 for 5 days
干预措施: Arctuvan (Drug)
Uva Ursi
placebo to fosfomycin: 3 g granules orally 1x1 (day 0)
and
Uva Ursi: 105 mg (Arctuvan®) 3x2 tablets orally from day 0 for 5 days
干预措施: Placebo to Fosfomycin (Drug)
fosfomycin
fosfomycin (Monuril®): 3 g granules orally 1x1 (day 0),
and
placebo to Uva Ursi: 3x2 tablets orally from day 0 for 5 days
If the patient returns with persistent/recurrent symptoms, antibiotic therapy according to the sensitivity test.
干预措施: Fosfomycin (Drug)
fosfomycin
fosfomycin (Monuril®): 3 g granules orally 1x1 (day 0),
and
placebo to Uva Ursi: 3x2 tablets orally from day 0 for 5 days
If the patient returns with persistent/recurrent symptoms, antibiotic therapy according to the sensitivity test.
干预措施: Placebo to Arctuvan (Drug)
结局指标
主要结局
antibiotic courses
时间窗: day 0-28
number of antibiotic courses from day 0 to day 28
symptom burden
时间窗: day 0-7
symptom burden (AUC) from day 0 to day 7
次要结局
- early relapses(day 0-14)
- AE and SAE(day 0-28)
- activity impairment by UTI symptoms, measured as AUC(day 0-7)
- painkillers(day 0-7)
- antibiotic use(day 0-28)
- UTI related sick leave(day 0-28)
- patients taking painkillers(day 28)
- UTI related visits(day 0-28)
- symptom sum score by patients' questionnaire(day 0-7)
- symptom burden negative urine culture(day 0-7)
- symptom burden for lower abdominal pain(day 0-7)
- symptom resolution(day 4 and 7)
- patients with poor outcome: prolonged symptoms(day 0-28)
- pyelonephritis(day 0-28)
- patients with at least 1 AE/ 2 AE(day 28)
- symptom burden for urgency(day 0-7)
- symptom burden for frequency(day 0-7)
- recurrent UTI(day 15-28)
- symptom burden for dysuria(day 0-7)
- symptom burden positive urine culture(day 0-7)
- patients with poor outcome: temperature(day 0-7)
- patients with poor outcome: worsening symptoms(day 28)
研究者
Karsten Gavenis
Quality Assurance Staff Unit Clinical Trials
University Medical Center Goettingen