Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- measure the levels of posaconazole post dosing
研究概览
简要总结
This is a single center, observational study of posaconazole PK sampling in lung transplant recipients. The patients enrolled will have up to 6 (3ml) pk samples (a total of 18 ml) and one 10ml blood sample for a total collection of 28ml of blood obtained over the entire study. In addition, the investigators will collect medical record information and any excess BAL samples available during the study (tests done as part of the patient's clinical care and the samples would have been discarded once diagnosis was made).
详细描述
PK blood samples will be obtained around a clinical dosing of posaconazole
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •18 years of age and older receiving posaconazole post transplant as part of their care received a lung transplant
排除标准
- •must meet inclusion criteria
结局指标
主要结局
measure the levels of posaconazole post dosing
时间窗: 24 hours after dosing
pk samples will be obtained around dosing of medication and then analyzed for posaconazole levels
次要结局
- determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells(1 year)