Intraperitoneal (IP) Vancomycin Plus Oral Moxifloxacin Versus IP Vancomycin Plus IP Ceftazidime for the Treatment of Peritoneal Dialysis-related Peritonitis: a Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Complete Cure Rate
研究概览
简要总结
Intra-peritoneal administration of antibiotics covering both gram-positive and gram-negative organisms was recommended as first-line regimen for the management of peritoneal dialysis related peritonitis. Oral administration of quinolones can also achieve effective serum concentrations, and is more convenient and economical. We conducted a pilot randomized controlled study to compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime.
详细描述
To compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime, eligible PD patients were randomly assigned to study group (IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD) and control group (IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD). Patients were followed for 3 months after the completion of the treatment period. Primary endpoint is complete cure, secondary endpoint are primary response and primary or secondary treatment failure.
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
- Single (Outcomes Assessor)
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
- •incident or prevalent peritoneal dialysis patients
- •diagnosis of acute peritonitis according to ISPD guideline
- •age >18 years
排除标准
- •receiving antibiotic treatment for other reasons when peritonitis occurred
- •contraindication to cephalosporin, vancomycin, or fluoroquinolones
- •concomitant exit-site or tunnel infection
- •requirement for immediate transfer to hemodialysis due to sepsis, gastrointestinal perforation or visceral inflammation, severe bowel obstruction, or ultrafiltration failure at the initiation of peritonitis
- •inability to tolerate oral administration due to severe gastrointestinal complication or other reasons
- •history of psychological illness or condition which interfered with ability to understand or comply with the requirements of the study
- •pregnant or breast-feeding
研究组 & 干预措施
Control group
IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD. The duration of treatment was based on internatinal society of peritoneal dialysis (ISPD) guideline recommendations.
干预措施: vancomycin (Drug)
Control group
IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD. The duration of treatment was based on internatinal society of peritoneal dialysis (ISPD) guideline recommendations.
干预措施: ceftazidime (Drug)
study group
IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.
干预措施: vancomycin (Drug)
study group
IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.
干预措施: moxifloxacin (Drug)
结局指标
主要结局
Complete Cure Rate
时间窗: within 4 weeks of completion of therapy
complete cure was defined as complete resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) by using antibiotics alone without relapse within 4 weeks of completion of therapy
次要结局
- Primary Response Rate(on day 10 by using antibiotics alone)
- Primary Treatment Failure Rate(after 3 days of treatment by the assigned antibiotics)
- Secondary Treatment Failure Rate(after 6 to 8 days of treatment)
研究者
Dong Jie
Professor
Peking University First Hospital