Bioavailability of Voriconazole

NCT02110316 | Withdrawn Phase 4

• 1 other identifier: 47955
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Voriconazole; Bioavailability; Critically Ill

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Correlation of bioavailability of voriconazole with disease severity

  1 day

• Correlation of bioavailability of voriconazole with the degree of inflammation

  1 day

Study Arms (1)

Bioavailability

OTHER

1 arm, different dosage form

Other: Dosage form of voriconazole

Interventions

Dosage form of voriconazole OTHER

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

Bioavailability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 yrs;
• Treatment with voriconazole;
• Admission to an ICU;
• Written informed consent.

You may not qualify if:

• Blood sampling by central venous catheter or peripheral cannula not possible;
• Concomitantly using a strong inhibitor or inducer of cytochrome P450.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan-Willem Alffenaar, PharmD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD, PhD

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 10, 2014
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2016-02

Locations

NL (1)