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临床试验/NCT00920270
NCT00920270Unknown3 期

Efficacy and Safety of Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia Caused by Gram Negative Bacteria

Mahidol University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2006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
140
试验地点
1
主要终点
Clinical response

研究概览

简要总结

Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram Negative Bacteria should be more effective than conventional therapy

详细描述

Randomized Controlled Clinical Trial in hospitalized adult patients with hospital-acquired pneumonia. The patients are allocated to conventional group or nebulized colistin group. The conventional group receives conventional antibiotics whereas the nebulized colistin group receives nebulized colistin in addition to conventional antibiotics. The outcomes are clinical response and microbiological responses.

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

  • Adult (age>18 years) hospitalized patient with hospital-acquired pneumonia due to Gram negative bacteria

排除标准

  • pregnancy
  • lactating woman
  • colistin allergy
  • severe renal impairment

研究组 & 干预措施

antibiotic

Active Comparator

conventional antibiotics

干预措施: antibiotics (Drug)

colistin group

Experimental

nebulized colistin

干预措施: nebulized colistin (Drug)

结局指标

主要结局

Clinical response

时间窗: 14 days after Treatment

次要结局

  • Microbiological response and safety(14 days after treatment)

研究者

申办方类型
Other

研究点 (1)

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