A Randomized Controlled Trial of Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Extended-Spectrum ß-lactamase-producing Escherichia Coli
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- no symptoms of urinary tract infection
研究概览
简要总结
The aim of the investigators' study was to evaluate oral and non carbapenem antimicrobial agents which can be used in outpatient for the treatment of non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli. This study was conducted to compare the clinical and bacteriological outcomes of patients with non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli who were treated with intravenous (IV) carbapenems followed by oral sitafloxacin or IV ertapenem.
详细描述
A prospective randomized controlled trial of patients with a presumptive diagnosis of acute pyelonephritis caused by Extended Spectrum Beta Lactamase-producing pathogen was performed. Carbapenems was initially given to all patients. After day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. The regular course of treatment was completed within 10 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 pyelonephritis by definition
- •Positive urine culture for Extended Spectrum Beta Lactamase Escherichia coli ≥105 colony forming unit/mL
- •Voluntarily consented to be enrolled in the study
排除标准
- •Severe sepsis or septic shock
- •Mixed organism of urine culture
- •Positive blood culture
- •Has other source of infection
- •Has mechanical abnormality of urinary tract
- •Immunocompromised conditions
- •Retained Foley's catheter
- •Pregnancy or lactation
- •Previous urinary tract infections within 4 weeks
- •Contraindicated for fluoroquinolones and carbapenems
研究组 & 干预措施
Sitafloxacin group
The first third days of treatment was open label and all patients were given intravenous carbapenems. After day 3, the patients were randomized to either sitafloxacin group or ertapenem group by the use of a computer-generated random number allocation schedule and block size of four. The patients were allocated to the sitafloxacin group or ertapenem group using the sealed envelope method.
干预措施: Sitafloxacin (Drug)
control group
Intervention was prescribed ertapenem for patients.
干预措施: Ertapenem (Drug)
结局指标
主要结局
no symptoms of urinary tract infection
时间窗: 30 days
no fever, dysuria, back pain, nausea and vomiting
次要结局
- no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture(30 days)
研究者
Chitprasong Malaisri
Ramathibodi Hospital
Mahidol University