An Open Label Non Placebo Study to Evaluate Efficacy and Safety of Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
试验速览
- 阶段
- 4 期
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Percentage of patients with clinical cure rates at test of cure visit (TOC) defined as follows- Cure: a complete resolution of clinically significant signs & symptoms
研究概览
简要总结
Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI
详细描述
A complicated urinary tract infection is a urinary infection occurring in a patient with a structural or functional abnormality of the genitourinary tract.
Fluoroquinolones have been recommended as the antimicrobials of choice for the empirical treatment of complicated urinary tract. Levofloxacin is a broad spectrum agent, which is known to demonstrate good clinical efficacy against urinary tract infection (UTI).
There is no published evidence available on the empirical use of Levofloxacin 500 mg OD and its optimal duration of therapy in patients with Complicated Urinary Tract Infections (cUTI). The present study evaluates the efficacy and safety, and optimal duration of therapy of levofloxacin 500 mg OD in patients with complicated UTI.
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
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or non-pregnant women over 18 years of age with cUTI in
- •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.
- •Neurogenic bladder.
- •Obstructive uropathy due to lithiasis, tumor or fibrosis.
- •Acute urinary retention in men
排除标准
- •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
Levofloxacin 5 days
Levolet 500 mg given for 5 days
干预措施: Levofloxacin (Drug)
Levofloxacin 10 days
Levolet 500 mg given for 10 days
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Percentage of patients with clinical cure rates at test of cure visit (TOC) defined as follows- Cure: a complete resolution of clinically significant signs & symptoms
时间窗: Baseline to 5 days
Cure: a complete resolution of clinically significant signs \& symptoms
次要结局
- No. of adverse events in entire study duration(Baseline to EOT visit (Baseline to 15 days))
- Percentage of patients with microbiological eradication at test of cure visit (TOC)(Baseline to 5 days and upto 10 days)
- Percentage of patient compliant to therapy in each study arm.(Baseline to EOT visit (Baseline to 15 days))
- Percentage of patient samples sensitive to levofloxacin in each study arm.(Baseline to EOT (Baseline to 15 days))