Effect of Inflammation on Pharmacokinetics of Posaconazole
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L
研究概览
简要总结
Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis.
详细描述
A prospective observational study will be performed at the University Medical Center Groningen, the Netherlands using longitudinal data collection. The design of the study will be that patients starting on posaconazole treatment will be evaluated. After informed consent is obtained medical data will be collected from the medical chart. Posaconazole plasma concentration (trough levels) and inflammatory markers (e.g. C-reactive protein) will be determined in all samples available from routine analysis (often daily). This will result in a detailed data set capturing day to day variations in inflammation and drug concentrations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •receiving posaconazole
- •Written informed consent
排除标准
- 未提供
研究组 & 干预措施
posaconazole-group
patients receiving posaconazole for prophylaxis or treatment of invasive fungal infection
干预措施: posaconazole (Drug)
结局指标
主要结局
C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L
时间窗: 6 months after start of treatment
Posaconazole drug exposure during treatment in different stages of inflammation. To determine the differences in concentrations between patients a random additive effect was used. Additionally, to correct for differences in intervals between observations a first-order autoregressive correlation was used. The Wald type III test was used to assess the influence of inflammation on posaconazole concentration.
次要结局
未报告次要终点
研究者
Jan-Willem C Alffenaar
PharmD PhD
University Medical Center Groningen