NL-OMON40371已完成不适用
Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) - TAPAS-PK study in patients with CF
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
- •* Age * 18 years;
- •* FEV1 predicted * 30%;
- •* Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;
- •* Chronic PA colonization requiring;
- •* Ability to breathe through a mouthpiece and to use the inhaler;
- •* Ability to perform lung function tests;
- •* Written informed consent.
排除标准
- •* Severe acute exacerbation of pulmonary infection (needing intravenous treatment);
- •* Patients receiving intravenous tobramycin treatment;
- •* Patients who are pregnant, planning to become pregnant or breastfeeding;
- •* Known impaired kidney function (estimated creatinine clearance < 60 ml/min);
- •* Known aminoglycoside hypersensitivity;
- •* Therapy (e.g. furosemide) or disease which may complicate evaluation of the study protocol, as judged by the investigator;
- •* Participation in another drug-investigating clinical study at the start or within 1 month prior to the start;
- •* Inability to follow instructions of the investigator.
研究者
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