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临床试验/NCT02098486
NCT02098486已完成2 期

Antibiotic Prophylaxis for ERCP: a Comparison of Intravenous Ceftriaxone With Intravenous Moxifloxacin in the Prophylaxis of Cholangitis

Kangbuk Samsung Hospital1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
cholangitis

研究概览

简要总结

Background and aims: The use of prophylactic antibiotics before endoscopic retrograde cholangiopancreatography (ERCP) is recommended by all major international gastroenterological societies, especially in the presence of an obstructed biliary system. Their use is intended to decrease or eliminate the incidence of complications following the procedure, namely cholangitis, cholecystitis, septicemia, and pancreatitis. However, there were a few reports concerning the dosage, duration and adopting antibiotics most suitable for this purpose. The aim of this prospective comparative study is to compare the occurrence rate of post-procedural complications, such as cholangitis, bacteremia and septicemia between intravenous moxifloxacin and ceftriaxone for the prophylactic use in patients with bile duct obstruction who will undergo therapeutic ERCP procedure.

Methods: In this prospective study, a total of 160 patients (calculated by IBM SPSS Sample Power, version 3.0) with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc) will be enrolled and randomly allocated to intravenous moxifloxacin and ceftriaxone group, respectively (using simple randomization program). Intravenous moxifloxacin (400 mg/day, infused more than 60 min) or ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min) will be given 90 minutes before ERCP procedure, and will be given to a patient for more than 3 days if the patient develops symptoms and signs of cholangitis or septicemia.

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
None

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc)

排除标准

  • pregnancy
  • hypersensitivity to moxifloxacin and/or ceftriaxone
  • previous antibiotic exposure or theophyllin derivatives medication within 14 days of admission
  • previous history of epilepsy
  • previous history of endocarditis of valvular heart disease

研究组 & 干预措施

Ceftraxone

Active Comparator

ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min)

干预措施: ceftriaxone (Drug)

Moxifloxacin

Active Comparator

Intravenous moxifloxacin (400 mg/day, infused more than 60 min)

干预措施: Moxifloxacin (Drug)

结局指标

主要结局

cholangitis

时间窗: 3 days

To compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group

次要结局

  • 30 day mortality(30 days)

研究者

发起方
Kangbuk Samsung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Joo Kim

Associate Professor

Kangbuk Samsung Hospital

研究点 (1)

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