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临床试验/NCT01542801
NCT01542801已完成4 期

Comparison of Daily Norfloxacin Versus Weekly Ciprofloxacin for the Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Korea University7 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2011年8月最近更新:
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
124
试验地点
7
主要终点
The prevention rate of spontaneous bacterial peritonitis (SBP)

研究概览

简要总结

  • For the prevention of spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis, norfloxacin 400mg per day is a standard regimen.
  • Ciprofloxacin 750 mg per week is also known to be effective for prevention of SBP. In addition, ciprofloxacin once weekly administration is more convenient and less costly.
  • Therefore ciprofloxacin once weekly could be more useful if the the efficacy is comparable to norfloxacin once daily.
  • This study aims to prove ciprofloxacin once weekly administration is as effective as norfloxacin once daily administration for the prevention of SBP in cirrhotic patients with ascites.

详细描述

Spontaneous bacterial peritonitis (SBP) is one of the most serious complication of liver cirrhosis.

The short term mortality reaches 20-30% mainly due to sepsis, hepatorenal syndrome, and liver failure. In addition, patients who suffered SBP show poor prognosis with 1 year-mortality of 50-70%. The high recurrence rate is also problematic. Therefore appropriate prevention of SBP is critically needed to improve survival as well as quality of life.

Selective intestinal decontamination (SID) is eradicating gram negative bacterial in the gut lumen, and effectively prevent development of SBP. Patients with gastrointestinal hemorrhage, low ascitic protein level, high bilirubin, or history of SBP need SID.

Norfloxacin 400 mg daily administration decreased the incidence of SBP to 2% compared with 17% of no prevention group's among patients with ascitic protein less than 1.5 g/dL. Also, in high risk patients (Child-Pugh score > or = 9 points and serum bilirubin level > or = 3 mg/dL, serum creatinine level > or = 1.2 mg/dL, blood urea nitrogen level > or = 25 mg/dL, or serum sodium level < or = 130 mEq/L), norfloxacin 400 mg/day improved 1 year-survival to 60% compared with 48% of no prevention group's. Therefore norfloxacin is now primarily recommend for the prevention of SBP in cirrhotic patients. However, norfloxacin should be administered on daily basis, so efforts to reduce cost and frequency have been made.

Ciprofloxacin 750 mg weekly administration has been evaluated, and shown to be effective as 3.6% versus 22% in prevention versus no prevention arm, respectively. Therefore, ciprofloxacin 750 mg/week is a reasonable option for prevention of SBP. However, comparison of efficacy of these two methods (norfloxacin 400 mg daily versus ciprofloxacin 750 mg weekly) has not been performed, yet.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 20-75 years old
  • Liver cirrhosis with ascites
  • Ascitic polymorphonucleated cells (PMN) count < 250/mm3
  • Ascitic protein <= 1.5 g/dL or History of SBP

排除标准

  • Incompatibility with inclusion criteria
  • Hypersensitivity or intolerability with quinolones
  • Hepatocellular carcinoma beyond Milan Criteria
  • Hepatic encephalopathy over stage 2
  • History of treatment with antibiotics within 2 weeks of enrollment
  • HIV infection
  • Untreated malignancy
  • Women with child-bearing age not willing to use effective contraception.
  • Pregnant or breast feeding women
  • Not able to give informed consents

研究组 & 干预措施

Norfloxacin

Active Comparator

norfloxacin 400 mg once daily administration

干预措施: Norfloxacin (Drug)

Ciprofloxacin

Experimental

Ciprofloxacin 750 mg per week

干预措施: ciprofloxacin (Drug)

结局指标

主要结局

The prevention rate of spontaneous bacterial peritonitis (SBP)

时间窗: 12 months

The incidence of SBP will measured in each the group. Thereby, prevention rate will also be compared between the groups.

次要结局

  • 1 year mortality(12 months ( 1 year))
  • Incidence of infectious event other than SBP(12 months)
  • Hepatorenal syndrome(12 months)
  • Hepatic encephalopathy(12 months)
  • Adverse event of drugs(12 months)

研究者

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

Soon Ho Um

Professor of Medicine

Korea University

研究点 (7)

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