Multicentre, Prospective, Comparative, Randomized, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of Cefditoren Pivoxil vs. Ciprofloxacin in Uncomplicated Acute Cystitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 611
- 试验地点
- 30
- 主要终点
- Microbiological efficacy
研究概览
简要总结
The main objective of the study is to comparatively assess the efficacy and tolerability of the drugs under study in the treatment of acute uncomplicated cystitis.
详细描述
Urinary tract infections (UTI) are one of the most frequent reasons of surgery visits in Primary Care. More than 95 percent of UTIs are monomicrobial, although the microorganisms implied are varied, and the range of effective drugs could be extensive. The species most frequently isolated is Escherichia coli, with prevalence ranking between 85 and 90 percent of documented cases. E. coli has developed resistance to different antibiotics. Cefditoren is situated as a good candidate for the treatment of uncomplicated UTIs due to its spectrum of activity against E. coli. The study has been designed in accordance with the guidelines and recommendations in force to assess the efficacy of cefditoren pivoxil against ciprofloxacin, a drug which despite the increasing rate of resistance in some countries, continues to be a drug of choice for the treatment of uncomplicated UTIs.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant adult females (>= 18)
- •Clinical signs and symptoms of uncomplicated acute cystitis (dysuria, urgency, frequency, suprapubic pain) with symptoms starting <=72 hours prior the study entry
- •Positive pre-treatment clean-catch midstream urine culture (>= 103 CFU/ml) and pyuria (10 leukocytes/mm3 or more than 5 leukocytes/field 40x magnification) within the 48 hours prior to inclusion in the study
- •In vitro susceptibility testing of the isolated uropathogen to the drugs under study
- •Written informed consent
排除标准
- •Woman who are pregnant, nursing or not using a medically accepted, effective method of birth control
- •Three or more episodes of uncomplicated acute infections of the urinary tract during the past 12 months
- •Symptoms starting >4 days prior to admission
- •Body temperature >= 38.3ºC, back pain, chills or other manifestations suggestive of upper urinary infection
- •Evidence of structural or functional alterations of the urinary tract, such as calculi, stenosis, primary renal disease (eg. polycystic renal disease) or neurogenic bladder
- •Underlying disease predisposing to complicated urinary tract infections such as diabetes mellitus, immunosuppression, leucopenia, heart insufficiency, liver impairment and neoplastic processes
研究组 & 干预措施
1
Cefditoren pivoxil
干预措施: cefditoren pivoxil (Drug)
2
Ciprofloxacin
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Microbiological efficacy
时间窗: 5-9 days post-therapy
次要结局
- Clinical efficacy(5-9 days post-therapy)