The Efficacy of Prolonged Antibiotic Therapy for the Prevention of Relapsing Peritonitis in Peritoneal Dialysis Patients With High Dialysis Effluent Bacterial DNA Fragment Levels
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- repeat peritonitis episodes
研究概览
简要总结
Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent peritonitis remains the major cause of peritoneal failure. A recent study showed that an elevated bacterial DNA fragment levels in PD effluent 5 days prior to the completion of antibiotics predicts the development of relapsing or recurrent peritonitis episodes. We hypothesize that prolonged antibiotic therapy in PD patients with peritonitis and high PD effluent bacterial DNA fragment levels could prevent the development of relapsing and recurrent peritonitis. We plan to conduct a randomized control study of 360 patients with PD peritonitis. After inform consent, they will be randomized to receive one additional week of the effective antibiotic treatment (the Preemptive Treatment Group) or no additional treatment (the Control Group). Specimens of PD effluent will be collected 5 days prior to the completion of antibiotics for the measurement of bacterial DNA fragments. All patients will be followed for 6 months after completion of antibiotic therapy for the development of relapsing, recurrent, or repeat peritonitis episodes. Our study will determine the efficacy of a test-before-treat algorithm that could reduce the incidence of relapsing and recurrent peritonitis and, at the same time, minimize the unnecessary use of prolonged antibiotic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients with peritoneal dialysis-related peritonitis
排除标准
- •Patients with fungal peritonitis
- •Patients with obvious surgical problems and require laparotomy
研究组 & 干预措施
Treatment
One extra week of antibiotic therapy
干预措施: Extended antibiotics (cefazolin or ceftazidime) (Drug)
Control
No extra antibiotics
干预措施: Usual antibiotics (cefazolin or ceftazidime) (Drug)
结局指标
主要结局
repeat peritonitis episodes
时间窗: 6 months
relapsing peritonitis episodes
时间窗: 6 months
recurrent peritonitis episodes
时间窗: 6 months
次要结局
- all cause mortality(6 months)
- peritonitis that requires hospitalization(6 months)
- need of catheter removal(6 months)
- need of conversion to long-term hemodialysis(6 months)
- death due to peritonitis(6 months)
研究者
Cheuk-Chun SZETO
Professor
Chinese University of Hong Kong
