Bioavailability of Voriconazole
Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Voriconazole; Bioavailability; Critically Ill
Intervention: Dosage form of voriconazole (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Medical Center Groningen Official(s) and/or principal investigator(s): Jan-Willem Alffenaar, PharmD, PhD, Principal Investigator, Affiliation: University Medical Center Groningen
Overall contact: Jan-Willem Alffenaar, PharmD, PhD, Phone: +31503614070, Email: j.w.c.alffenaar@umcg.nl
Summary
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.
Clinical Details
Official title: Bioavailability of Voriconazole in Critically Ill Patients
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: The bioavailability of voriconazole in critically ill patients
Secondary outcome: Correlation of bioavailability of voriconazole with disease severityCorrelation of bioavailability of voriconazole with the degree of inflammation
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Jan-Willem Alffenaar, PharmD, PhD, Phone: +31503614070, Email: j.w.c.alffenaar@umcg.nl
University Medical Center Groningen, Groningen 9700 RB, Netherlands; Recruiting Jan-Willem Alffenaar, PharmD, PhD, Phone: +31503614070, Email: j.w.c.alffenaar@umcg.nl Jan-Willem Alffenaar, PharmD, PhD, Principal Investigator
Additional Information
Starting date: June 2015
Last updated: June 17, 2015
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