NCT00239161终止4 期
TREATMENT OF ACUTE UNCOMPLICATED PYELONEPHRITIS WITH SHORT COURSE LEVOFLOXACIN A Pilot Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Microbiological cure at the 10-14 day and 33-35 day followup
研究概览
简要总结
The purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin using a shorter course of therapy to treat patients with infections of their kidney.
详细描述
The goal is to complete a pilot study of short course (5 days), high dose, levofloxacin treatment for women with acute uncomplicated pyelonephritis. Specific study objectives include:
- To assess the efficacy and tolerability of levofloxacin 750 mg once daily for treatment of acute uncomplicated pyelonephritis in 25 women.
- To describe the population pharmacokinetics of levofloxacin 750 mg once daily in treatment of young women with acute pyelonephritis.
- To identify urine proteins associated with the inflammatory response of acute pyelonephritis, and characterize the time course of resolution of these proteins following initiation of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •·Pregnancy, breastfeeding, fluoroquinolone allergy, and any underlying structural or functional genitourinary abnormality.
结局指标
主要结局
Microbiological cure at the 10-14 day and 33-35 day followup
次要结局
- Clinical outcome at each visit. Microbiologic outcomes at 24,48,and72 hrs, adverse antimicrobial effects, adverse events or antimicrobial resistance. Correlation between pharmacodynamic parameters, bacteriologic and clinical resolution will be analyzed.
研究者
研究点 (8)
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