2024-518337-29-00招募中4 期
Pulmonary pharmacokinetics of piperacillin/tazobactam and levofloxacin in patients with chronic obstructive pulmonary disease or cystic fibrosis: Comparison of epithelial lining fluid, in-vivo microdialysis and tissue biopsy. An exploratory pharmacokinetic study.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Antibiotic concentrations in ELF and tissue biopsy at 75' and in-vivo microdialysis concentrations during the 60-90' interval.
研究概览
简要总结
The primary objective is the head-to-head comparison of three methods for measuring pulmonary antibiotic pharmacokinetics. Epithelial lining fluid concentrations at 75', tissue biopsy concentrations at 75' and in-vivo microdialysis concentrations during the 60-90' interval will be compared.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Planned bilateral lung transplantation
- •Diagnosis of COPD or CF
- •Age: > 18 and < 90 years
排除标准
- •Inability to give informed consent
- •Known allergy to study drugs
- •Prior lung transplantation
- •Preoperative renal failure
- •Chronic severe renal insufficiency including haemodialysis
- •Chronic severe liver disease
- •ECLS bridging
结局指标
主要结局
Antibiotic concentrations in ELF and tissue biopsy at 75' and in-vivo microdialysis concentrations during the 60-90' interval.
Antibiotic concentrations in ELF and tissue biopsy at 75' and in-vivo microdialysis concentrations during the 60-90' interval.
次要结局
未报告次要终点
研究者
Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine
Scientific
Medical University Of Vienna
研究点 (1)
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