NCT01420562招募中不适用
Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Posaconazole plasma levels and area under the curve in patients with different stages of mucositis
研究概览
简要总结
The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving allogeneic stem cell transplantation - Treated with prophylactic posaconazole: oral suspension (200mg three times daily) or tablet (300mg once daily) to prevent invasive fungal infections
排除标准
- •Gastroparesis
- •Vomiting or diarrhea within 2 hours after intake of posaconazole
- •Concomitant administration of potent inducers of the enzyme UGT1A4: carbamazepine,phenytoin, phenobarbital, rifabutin, rifampicin,...
- •Age under 18 years
结局指标
主要结局
Posaconazole plasma levels and area under the curve in patients with different stages of mucositis
时间窗: Day 0 (day of transplantation), day +7, day +14
Plasma levels of posaconazole will be determined to calculate the area under the curve. These values will be correlated with the stage of mucositis, which will be assessed using citrulline monitoring in plasma. The stage of mucositis will also be assessed using the Daily Oral Mucositis Score (DMS) and Daily Gut Mucositis Score (DGS).
次要结局
未报告次要终点
研究者
研究点 (1)
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