NCT01418846已完成不适用
Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Voriconazole pharmacokinetics in saliva and plasma in different patient populations
研究概览
简要总结
The purpose of this study is to investigate the intra-saliva penetration of voriconazole in different subpopulations. The goal is to develop, optimize and validate an easy, non-invasive and painless procedure for Therapeutic Drud Monitoring of voriconazole that can be used in children, ambulatory patients and in patients in whom blood drawing is difficult.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients from the adult hematology ward treated with voriconazole
- •pediatric patients treated with voriconazole, age 5-18 years
- •patients from the pneumology ward treated with voriconazole
排除标准
- •Age under 5 years
- •Women who are pregnant or lactating
- •Mucositis stage 3 or 4 (WHO)
- •Patients which received the following drugs within 14 days before study entry: rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz and barbiturates.
- •Patients which received the following drugs within 24hours before study entry: quinidine, ergotamine, sirolimus, saquinavir, amprenavir, nelfinavir, ritonavir and sulphonylureas.
结局指标
主要结局
Voriconazole pharmacokinetics in saliva and plasma in different patient populations
时间窗: One day at steady state of voriconazole plasma levels
次要结局
未报告次要终点
研究者
研究点 (3)
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