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临床试验/NCT01785641
NCT01785641已完成不适用

Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in Continuous Ambulatory Peritoneal Dialysis Patients

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
relapse or recurrent rate

研究概览

简要总结

To compare the efficacy of single versus combined antibiotic therapy for bacterial peritonitis in CAPD patients.

详细描述

To compare relapse and recurrent rate of peritonitis between single and combined antibiotic regimens for bacterial peritonitis in CAPD patients.

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 (Participant)

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >/= 18 years old
  • ESRD patients on continuous ambulatory peritoneal dialysis more than 4 weeks
  • presence of symptom or sign of peritonitis
  • presence of WBC >100cell/mm3 with PMN >50% in peritoneal dialysate or gram stain positive for gram positive or gram negative bacteria

排除标准

  • presence of polymicrobial organism, non-fermentative gram negative organism, fungus, mycobacteria in peritoneal fluid or culture-negative
  • peritonitis from the organisms that required combined antibiotic therapy according to ISPD guideline 2010
  • hospital-acquired peritonitis
  • presence of catheter-related infection
  • history of peritonitis within 4 weeks
  • currently taking antibiotic
  • allergic to the antibiotic that used in the study(penicillin or cephalosporin or quinolone or aminoglycoside)

研究组 & 干预措施

cefazolin monotherapy

Active Comparator

cefazolin IP for gram positive bacterial peritonitis

干预措施: cefazolin monotherapy (Drug)

ceftazidime+ciprofloxacin

Experimental

2 synergistic antibiotics(ceftazidime IP and ciprofloxacin po for gram negative bacterial peritonitis)

干预措施: ceftazidime+ciprofloxacin (Drug)

ceftazidime monotherapy

Active Comparator

ceftazidime IP for gram negative bacterial peritonitis

干预措施: ceftazidime monotherapy (Drug)

cefazolin+gentamicin

Experimental

cefazolin IP and gentamicin IP for gram positive bacterial peritonitis

干预措施: cefazolin+gentamicin (Drug)

结局指标

主要结局

relapse or recurrent rate

时间窗: within 4 weeks after peritonitis treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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