Bioavailability of Voriconazole

Phase 4

Withdrawn

• Conditions: Voriconazole; Bioavailability; Critically Ill
• Interventions: Other: Dosage form of voriconazole

• Registration Number: NCT02110316
• Lead Sponsor: University Medical Center Groningen

Brief 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.

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.

Study Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-10
• Study Start: 2015-06
• Status Verified: 2016-02
• Primary Completion: 2016-06
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bioavailability	Dosage form of voriconazole	1 arm, different dosage form

Primary Outcome Measures

Name	Time	Method
The bioavailability of voriconazole in critically ill patients	1 day	Bioavailability will be determined by comparing the area under the concentration time curve (AUC) of an intravenous and oral dose of voriconazole.

Secondary Outcome Measures

Name	Time	Method
Correlation of bioavailability of voriconazole with disease severity	1 day	Disease severity will be determined using the APACHE IV score
Correlation of bioavailability of voriconazole with the degree of inflammation	1 day	To determine the degree of inflammation C-reactive protein (CRP) will be determined

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands