Bioavailability of Voriconazole

Critically Ill Clinical Trial

Official title:

Bioavailability of Voriconazole in Critically Ill Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02110316
• Other study ID #: 47955
• Status: Withdrawn
• Phase: Phase 4
• First received: April 7, 2014
• Last updated: September 1, 2016
• Start date: June 2015

Study information

• Verified date: February 2016
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioavailability
• Critical Illness
• Critically Ill
• Voriconazole

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The bioavailability of voriconazole in critically ill patients	Bioavailability will be determined by comparing the area under the concentration time curve (AUC) of an intravenous and oral dose of voriconazole.	1 day	No
Secondary	Correlation of bioavailability of voriconazole with disease severity	Disease severity will be determined using the APACHE IV score	1 day	No
Secondary	Correlation of bioavailability of voriconazole with the degree of inflammation	To determine the degree of inflammation C-reactive protein (CRP) will be determined	1 day	No