Bioavailability of Voriconazole
Bioavailability of Voriconazole in Critically Ill Patients
研究概览
详细说明
The bioavailability of voriconazole, based on healthy volunteers, is estimated to be >90%. Due to the high bioavailability of voriconazole, switching between oral and intravenous administration is permitted if clinically allowed. Few data are available for the bioavailability of voriconazole in critically ill patients. However, to obtain a therapeutic concentration of voriconazole (>1.5 mg/L, which is associated with a beneficial response to treatment) one study showed that a higher oral dose is required compared with the intravenous dose, to obtain this therapeutic concentration. Therefore, the pharmacokinetics can be changed in critically ill patients, including bioavailability.
In this study, patients who receive voriconazole orally (prescribed by their attending physician) will receive one intravenous dose of voriconazole instead of the oral dose. The intravenous dose will be the same as the oral dose voriconazole.
研究类型
阶段
- 第四阶段
联系人和位置
学习地点
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Groningen、荷兰、9700 RB
- University Medical Center Groningen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged ≥ 18 yrs;
- Treatment with voriconazole;
- Admission to an ICU;
- Written informed consent.
Exclusion Criteria:
- Blood sampling by central venous catheter or peripheral cannula not possible;
- Concomitantly using a strong inhibitor or inducer of cytochrome P450.
学习计划
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Bioavailability
1 arm, different dosage form
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Instead of an oral dose of voriconazole, patients receive one intravenous dose of voriconazole (in the same dose as the oral dose).
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The bioavailability of voriconazole in critically ill patients
大体时间:1 day
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Bioavailability will be determined by comparing the area under the concentration time curve (AUC) of an intravenous and oral dose of voriconazole.
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1 day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Correlation of bioavailability of voriconazole with disease severity
大体时间:1 day
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Disease severity will be determined using the APACHE IV score
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1 day
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Correlation of bioavailability of voriconazole with the degree of inflammation
大体时间:1 day
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To determine the degree of inflammation C-reactive protein (CRP) will be determined
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1 day
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 47955
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