NCT01537614已完成1 期
Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
研究概览
简要总结
Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI colimycin either as an aerosol or after IV injection, the administration being separated by 5 to 10 days intervals
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, adults.
- •Suffering from stable cystic fibrosis
- •Colonized by P. aeruginosa
- •Having given informed consent.
- •Able to follow the protocol
- •Having a social insurance
排除标准
- •Renal insufficiency
- •Allergy to colistin or polymixins
- •Myasthenia
- •Recent severe hemoptysis
- •Liver cirrhosis and hepatic insufficiency
- •Hypoalbuminemia
- •Colonization by Burkholderia cepaea or Stenotrophomonas maltophilin
- •Pregnancy
研究组 & 干预措施
COLIMYCINE injectable
Experimental
干预措施: COLIMYCINE injectable (Drug)
COLIMYCINE inhalation
Experimental
干预措施: COLIMYCINE inhalation (Drug)
研究者
研究点 (1)
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