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临床试验/NCT01297894
NCT01297894Unknown3 期

Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii

Mahidol University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
92
试验地点
1
主要终点
number of subjects with cure or improvement

研究概览

简要总结

In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients

详细描述

Inclusion criteria

  • Age> 18 years
  • Hospitalized to Siriraj Hospital
  • Infected caused by A. baumannii
  • Need Colistin treatment

Exclusion criteria

  • Pregnancy or Lactating mother
  • Colistin or Fosfomycin Allergy
  • Patients who have severe abnormal renal or liver function

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age> 18 years
  • Hospitalized to Siriraj Hospital
  • Infected caused by A. baumannii
  • Need Colistin treatment
  • Exclusion criteria:
  • Pregnancy or Lactating mother
  • Colistin or Fosfomycin Allergy
  • Patients who have severe abnormal renal or liver function

排除标准

  • 未提供

研究组 & 干预措施

colistin

Active Comparator

Colistimethate sodium 2.5-5mg/kg iv

干预措施: colistin (Drug)

colistin plus fosfomycin

Active Comparator

colistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours

干预措施: colistin plus fosfomycin (Drug)

结局指标

主要结局

number of subjects with cure or improvement

时间窗: up to 28days

cure improvement worse death

次要结局

  • number of subjects with eradication of causative bacteria(up to 28days)

研究者

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

Visanu Thamlikitkul

Division of Infectious Diseases and tropical medicine, Department of medicine, Faculty of Medicine Siriraj Hospital.

Mahidol University

研究点 (1)

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