NCT00245791终止4 期
TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN
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
- 3
- 主要终点
- Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).
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 and using a shorter course of therapy.
详细描述
This study will be a pilot study of the efficacy of 750 mg of levofloxacin once daily for 5 days in the treatment of complicated urinary tract infection.
The specific objectives include:
- To describe clinical and microbiological outcome at short and long term follow-up with 5 days levofloxacin in subjects with acute symptomatic complicated urinary infection, both with and without indwelling catheters.
- To determine the tolerability of levofloxacin 750-mg once daily in patients with complicated urinary infection.
- To describe some characteristics of the resolution of the inflammatory response with treatment of complicated urinary infection as demonstrated by changes in urine proteins.
- To identify any emergence of resistant organisms in recurrent urinary infection following therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acute symptoms of urinary infection of less than 7 days duration and an underlying structural or functional abnormality of the genitourinary tract.
- •Pre-therapy urine culture > 105 cfu/ml (> 108 cfu/L) of at least one urinary pathogen.
- •Age 18-80 years, male or female.
排除标准
- •Prior allergic reaction to any fluoroquinolone antimicrobial.
- •Known infection with a fluoroquinolone - resistant organism.
- •Requiring parenteral therapy because of severity of illness or unable to take oral medications.
- •Women who are pregnant or breastfeeding.
- •Requiring additional antimicrobial therapy for infections elsewhere.
结局指标
主要结局
Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).
次要结局
- Variables will include outcomes at 2 days of therapy, failure to complete therapy, adverse drug effects, long term clinical and microbiologic outcomes, and emergence of resistant organisms.
研究者
研究点 (3)
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