Urinary Bactericidal Activity of 4 Doses of Levofloxacin (250, 500, &750, and 1000 mg) Against Fluoroquinolone-Resistant E. Coli
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- evaluate the Urine Bactericidal Activity (UBA) of different doses and urine levels of levofloxacin against drug-resistant bacteria.
研究概览
简要总结
Single-dose studies of a fluoroquinolone are indicative of their antimicrobial activity since little accumulation occurs with multiple doses. Single-dose studies have been utilized to determine drug concentrations and time kill activity in serum, urine, and respiratory tissues.
The purpose of this study is to evaluate the Urine Bactericidal Activity (UBA) of levofloxacin (250, 500, 750, and 1000 mg) against FQ-resistant, ESBL positive E. coli isolates. In addition, a susceptibility breakpoint concentration in the urine can also be established for each dose of levofloxacin. Furthermore, urine concentrations and serum pharmacokinetic parameters of levofloxacin can be determined.
详细描述
Subjects: -10 healthy (from medical history) adult male or female volunteers
- Normal body weight (within 20 %)
- Age range: 18-60
- Not taking any other restricted medications (ie. antibiotics)
Drug : all drugs are a single dose given after a 12 hour fast
- 1000 mg.levofloxacin
- 750 mg. levofloxacin
- 500 mg levofloxacin
- 250 mg levofloxacin
Levofloxacin Pharmacokinetic Study:
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy (from medical history) adult male or female volunteers
- •Normal body weight (within 20 %)
- •Age range: 18-60
- •Not taking any other restricted medications (ie. antibiotics)
排除标准
- •Non-healthy volunteers
- •pregnant women
- •volunteers on other antibiotics
- •body weight over 20% of normal
- •Age <18 or >60
结局指标
主要结局
evaluate the Urine Bactericidal Activity (UBA) of different doses and urine levels of levofloxacin against drug-resistant bacteria.
次要结局
未报告次要终点