DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 severity

Correlation 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017