Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting. A Randomized, Double Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- The proportion of patients with resolution of symptoms on day 4
研究概览
简要总结
We propose to perform a randomized controlled patient and assessor blind trial in women between the ages of 18 to 70 years with acute uncomplicated UTI to evaluate initial symptomatic treatment for 3 days with the non-steroidal anti-inflammatory drug diclofenac (experimental intervention) against immediate antibiotic treatment with norfloxacin for 3 days (control intervention). Both interventions are followed by optional delayed antibiotic treatment with single dose fosfomycin if deemed necessary by the patients. The primary objective is to determine whether initial symptomatic treatment followed by optional delayed antibiotic treatment (experimental intervention) is non-inferior to immediate antibiotic treatment (control intervention) in terms of symptom resolution.
详细描述
Background
Urinary tract infection (UTI) is the most frequent bacterial infection diagnosed and treated by general practitioners and accounts for about 15% of antibiotic prescriptions in ambulatory medicine. World-wide raise of antibiotic resistance among uropathogens, most commonly Escherichia coli, threatens treatment of UTI. Uncomplicated UTI, the most frequent manifestation of UTI, is a benign, self-limited disease and the primary goal of treatment is symptom relief not cure. Antibiotic treatment reduces the duration of symptoms by 1-2 days from 5-6 days to 3-4 days. Symptoms of cystitis are the result of an inflammation evoked by bacterial products which stimulate the production of prostaglandins by a cyclooxygenase dependent mechanism. Therefore, we propose that symptom control with a non-steroidal anti-inflammatory drug (NSAID), an inhibitor of cyclooxygenase 1 and 2, may be equally effective for symptom control as standard antibiotic therapy in non-complicated UTI and may therefore help to reduce antibiotic consumption.
Objective
The primary objective is to determine whether initial symptomatic treatment followed by optional delayed antibiotic treatment (experimental intervention) is non-inferior to immediate antibiotic treatment followed by optional delayed antibiotic treatment (control intervention) in terms of symptom resolution.
The secondary objective is to determine whether the experimental intervention is superior to control in reducing the proportion of patients undergoing antibiotic treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Written informed consent
- •At least one typical symptom of acute, lower urinary tract infection out of dysuria, frequency, macrohaematuria, cloudy or smelly urine or self-diagnosed cystitis
- •A urine dipstick test should be indicative of UTI by positive nitrite or leucocyturia
- •Exclusion Criteria
- •Duration of UTI symptoms for more than 7 days before physician's visit
- •Clinical signs of invasiveness such as fever (axillary body temperature >38 degrees Celsius), costovertebral pain or tenderness, rigors, nausea or vomiting
- •Known or suspicion of anatomical or functional abnormality of the urinary tract
- •Vaginal symptoms: discharge, irritation
- •Diabetes mellitus
- •Immunosuppression (e.g. prednisone equivalent >10mg per day for >14 days, chemotherapy, radiotherapy, immunomodulators, HIV infection, neutropenia)
- •Any other serious comorbidity as judged by the treating physician
- •Bladder catheter in situ or during the past 30 days
- •Pregnancy
- •Recurrent urinary tract infection (more than 3 infections during the last 12 months)
- •Antibiotic treatment during the last 4 weeks
- •Hypersensitivity to one of the study medications
- •Psychiatric illness or dementia
- •Unable to communicate in German or French language
- •Documented coagulopathy (including therapy with coumarine derivatives) or documented history of gastric or duodenal ulcer disease
- •Documented renal insufficiency grade III or higher (calculated GFR <60) or known congestive heart failure (NYHA III or higher)
排除标准
- 未提供
研究组 & 干预措施
antibiotic
Norfloxacin for three days, followed by fosfomycin on day 4 if deemed necessary
干预措施: Norfloxacin (Drug)
symptomatic
Diclofenac retard for three days, followed by fosfomycin on day 4 if deemed necessary
干预措施: Diclofenac (Drug)
结局指标
主要结局
The proportion of patients with resolution of symptoms on day 4
时间窗: one month
次要结局
- The proportion of patients ever on antibiotics between randomization at day 1 and follow-up at day 30(one month)
- The proportion of patients using single dose fosfomycin on day 4(one month)
- The proportion of patients with re-consultations because of UTI within 30 days(one month)
- The mean composite symptom scores on days 4, 7 and 30(one month)
- The proportion of patients with resolution of symptoms on day 7(one month)
- The proportion of patients with complete resolution of symptoms on days 4 and 7(one month)
- The time until resolution of symptoms(one month)
- The proportion of patients with adverse events(one month)
- Mean overall patient stratification(one month)
- Health-related quality of life on day 4(one month)
- Number of working days lost(one month)