Critically Ill Clinical Trial
Official title:
Bioavailability of Voriconazole in Critically Ill Patients
The objective of this study is to obtain the absolute bioavailability of voriconazole in critically ill ICU patients, because pharmacokinetics can be different in critically ill patients due to alterations in function of various organs and body systems compared with healthy volunteers.
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.
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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