Sitafloxacin and Ertapenem Treatment for Acute Urinary Tract Infection Caused by E. Coli or K. Pneumoniae in Post-kidney Transplantation Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of patients with clinical cure of acute urinary tract infection
研究概览
简要总结
This study evaluates oral antimicrobial agents for the treatment of non-bacteremic acute urinary tract infection caused by Extended Spectrum Beta Lactamase producing Escherichia coli or Klebsiella pneumoniae in Post-kidney transplantation. Patients are treated with intravenous (IV) antibiotics follow by oral sitafloxacin or IV ertapenem.
详细描述
A prospective randomized controlled trial of patients with a presumptive diagnosis of acute urinary tract infection caused by Extended Spectrum Beta Lactamase-producing Escherichia coli or Klebsiella pneumoniae in Post-kidney transplantation. Intravenous (IV) antibiotic is initially given to all patients. After day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. The course of treatment will complete within 14 days.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Acute urinary infection by definitions
- •Positive urine culture for Extended Spectrum Beta Lactamase E. coli or K. pneumoniae ≥105 colony forming unit/mL
- •Post-kidney transplantation
- •Voluntarily consented to be enrolled in the study
排除标准
- •Positive blood culture
- •Mixed organism of urine culture
- •Immunocompromised conditions other than post-kidney transplantation
- •Pregnancy or lactation
- •Previous urinary tract infections within 4 weeks
- •Contraindicated for fluoroquinolones and carbapenems
研究组 & 干预措施
Sitafloxacin group
Sitafloxacin 100 mg oral twice daily
干预措施: Sitafloxacin (Drug)
Ertapenem group
Ertapenem 1 gm IV every 24 h
干预措施: Ertapenem (Drug)
结局指标
主要结局
Number of patients with clinical cure of acute urinary tract infection
时间窗: 14 days
No symptoms of acute urinary tract infection
次要结局
- Number of patients with micrological cure of acute urinary tract infection(14 days)
研究者
Atibordee Meesing, MD
Principal Investigator
Khon Kaen University