Bioavailability of Voriconazole

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Voriconazole Bioavailability Critically Ill

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Bioavailability

1 arm, different dosage form

Group Type OTHER

Dosage form of voriconazole

Intervention Type OTHER

Instead of an oral dose of voriconazole, patients receive one intravenous dose of voriconazole (in the same dose as the oral dose).

Interventions

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Dosage form of voriconazole

Instead of an oral dose of voriconazole, patients receive one intravenous dose of voriconazole (in the same dose as the oral dose).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No