跳至主要内容
临床试验/NCT02593201
NCT02593201已完成4 期

The Efficacy of Prolonged Antibiotic Therapy for the Prevention of Relapsing Peritonitis in Peritoneal Dialysis Patients With High Dialysis Effluent Bacterial DNA Fragment Levels

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 358 人开始时间: 2016年2月26日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

One extra week of antibiotic therapy

干预措施: Extended antibiotics (cefazolin or ceftazidime) (Drug)

Control

Sham Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheuk-Chun SZETO

Professor

Chinese University of Hong Kong

研究点 (1)

Loading locations...

相似试验