Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 主要终点
- number of urinary tract infection episodes during prophylaxis
研究概览
简要总结
Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract infections risked recurrent infection. Urinary tract infection causes marked discomfort for the patient, has a negative impact upon quality of life, and is associated with high social and health costs in terms of specialist appointments, laboratory and instrumental tests and prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been proposed, doubts persist about the most efficacious pharmacological agents, duration of prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is suspended.
Aims of the study:
- To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin):
- in reducing the number of urinary tract infection episodes during prophylaxis
- in reducing the number of urinary tract infection episodes after prophylaxis
- in improving the patient's quality of life .
- To assess :
- Tolerability of antibiotic prophylaxis
- The incidence of resistance to antibiotic therapy
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
- Single (Participant)
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
- •Female patients
- •Age over 18 years old
- •No allergies to the drugs to be prescribed
- •No counter-indications to this drug therapy
- •Urine culture shows responsiveness to drugs at recruitment of patient
- •History of urinary tract infections with at least three episodes in the previous year or two in the past six months
排除标准
- •Lack of tolerability of prescribed drugs
研究组 & 干预措施
Prulifloxacin
干预措施: prulifloxacin (Drug)
结局指标
主要结局
number of urinary tract infection episodes during prophylaxis
时间窗: 3 months
次要结局
- improving the patient's quality of life(1 year)