NCT00668122已完成3 期
Efficacy and Safety of Ciprofloxacin Extended-Release 1000 mg Once-Daily Versus Ciprofloxacin Immediate-Release 500 mg Twice-Daily Given 7-14 Days in Patients With Complicated Urinary Tract Infections: Prospective, Randomized, Double-Blind Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 212
- 主要终点
- Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).
研究概览
简要总结
To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR) tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet 500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial urinary tract infections (cUTI).
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
- All
- 接受健康志愿者
- 否
入选标准
- •The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18 years of age. Other main inclusion criteria:
- •One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation.
- •One or more of the following underlying conditions suggestive of cUTI:
- •Indwelling urinary catheter.
- •100 mL of residual urine after voiding.
- •Neurogenic bladder.
- •Obstructive uropathy due to lithiasis, tumor or fibrosis.
- •Acute urinary retention in men.
排除标准
- •Diagnosis of pyelonephritis supported by clinical signs/symptoms of fever (>38°C orally), chills and flank pain (all 3 signs/symptoms must be present).
- •Have a history of allergy to quinolones
- •Are unable to take oral medication
- •Have an intractable infection requiring > 14 days of therapy
- •Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
- •Have prostatitis or epididymitis
- •Have had a renal transplant
- •Have ileal loop or vesica- urethral reflux
- •Have significant liver or kidney impairment
- •Have a history of tendinopathy associated with fluoroquinolones
- •Are pregnant, nursing
- •Have a history of convulsions or CNS disorders
研究组 & 干预措施
Arm 1
Experimental
干预措施: Cipro XR (Ciprofloxacin, BAYQ3939) (Drug)
Arm 2
Experimental
干预措施: Cipro IR (Ciprofloxacin, BAYQ3939) (Drug)
结局指标
主要结局
Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).
时间窗: 5-9 days
次要结局
- Bacteriological outcome during treatment(7-14 days)
- Bacteriological outcome at follow-up(28-42 days)
- Clinical outcome during treatment(7-14 days)
- Clinical outcome at the test-of-cure visit(5-9 days)
- Clinical outcome at follow-up(28-42 days)
- Adverse event collection(28-42 days)
研究者
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