Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 494
- 试验地点
- 2
- 主要终点
- number of additional treatments with antibiotics combined with number of symptoms
研究概览
简要总结
In this study, patients with uncomplicated urinary infection are investigated. It is investigated if treatment of only symptoms of the uncomplicated urinary infection is as effective as treatment with antibiotics with respect to the outcome of the urinary infection. If this is the case, the use of antibiotics in the treatment of uncomplicated urinary infections might be reduced.
Secondary aim of the study is the safety evaluation of both treatment strategies with respect to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women (18 - 65 years)
- •Symptoms of uncomplicated urinary tract infection: dysuria, frequency/urgency of micturition, and/or low abdominal pain
- •written informed consent
排除标准
- •fever (> 38,0)
- •pain on renal bed percussion
- •signs of complicated urinary tract infection
- •urinary tract infection within the last two weeks
- •antibiotic intake within the last 7 days
- •repeated intake of pain medication (i.e. ibuprofen, diclofenac) within the last 24 hours, or continuous pain medication
- •known pregnancy/lactation period
- •current immunosuppressive therapy
- •known renal insufficiency
- •known renal abnormalities
- •current urine catheterization
- •serious neurological diseases
- •limited condition due to other disorders
- •contraindications towards trial medication
- •current/anamnestic gastrointestinal haemorrhagia
- •known allergy towards trial medication
- •current intake of drugs potentially interacting with trial medication (i.e. oral corticosteroids, anticoagulates)
- •poor communication/cooperation skills
- •disability to understand trial information, poor German language skills
- •current participation in another clinical trial or clinical trial participation within the last 4 weeks
研究组 & 干预措施
Ibuprofen
Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0
干预措施: Ibuprofen (Drug)
Fosfomycin-Trometamol
Fosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days
干预措施: Fosfomycin-Trometamol (Drug)
结局指标
主要结局
number of additional treatments with antibiotics combined with number of symptoms
时间窗: day 0-28
The study outcome is considered as positive, if the interventional group where only symptoms were treated has less additional treatments with antibiotics as the interventional group, where antibiotics are given from day 0 on. Additionally, the interventional group where only symptoms were treated has to be non inferior with respect to number of symptoms.
次要结局
- number of relapses(day 0-28)
- number of patients without symptoms(day 4 and day 7)
- symptom load (AUC)(day 0-4)
- symptom load(day 0-7)
- symptoms load with regard to specific symptoms(day 0-7)
- number of SAEs(day 0-28)
- number of defined daily doses of antibiotics(day 0-28)
- activity impairment assessment(day 0-7)