Voriconazole | Bioavailability of Voriconazole
Voriconazole research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Dosage form of voriconazoleInstead of an oral dose of voriconazole, patients receive one intravenous dose of voriconazole (in the same dose as the oral dose).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Bioavailability1 arm, different dosage form
Start Date: June 2015
Phase: Phase 4
Primary Outcome: The bioavailability of voriconazole in critically ill patients
Secondary Outcome: Correlation of bioavailability of voriconazole with disease severity
Study sponsors, principal investigator, and references
Principal Investigator: Jan-Willem Alffenaar, PharmD, PhD
Lead Sponsor: University Medical Center Groningen