NL-OMON38737已完成不适用
Pharmacokinetics of nasally administered tobramycin and colistin in Cystic Fibrosis - SPOEL study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Confirmed diagnose of Cystic Fibrosis based on genotyping or a positive sweat test
- •2. Age >= 18 years
- •3. Intravenous course of tobramycin in the past, but within the age of >= 18 years, with a creatinine value measured during that same intravenous course of tobramycin
排除标准
- •1. Kidney dysfunction (defined as estimated Glomerular Filtration Rate of < 50 ml/min)
- •2. Liver dysfunction (defined as at least one of the liver enzymes >= 3 times the normal value)
- •3. Intravenous treatment with aminoglycosides or polymyxins <= 48 hours
- •4. Acute pulmonary exacerbation (defined by Fuchs criteria)
- •5. Allergy or intolerance for aminoglycosides or polymyxins
- •6. Recent surgery of ear, nose or sinuses (< 3 months before study entry)
研究者
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