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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?

Voriconazole

Bioavailability

Critically Ill

Study Interventions

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).

Study Arms

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

Study Status

Withdrawn

Start Date: June 2015

Completed Date:

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02110316

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