Pharmacologic Optimization of Voriconazole

Summary

The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to the current standard of care.

Conditions

• Invasive Fungal Infection
• Hematological Malignancy

Interventions

DRUG

voriconazole

TDM (through level of 2-5mg/L).

DRUG

voriconazole (dosing according to the SPC)

No serum concentrations are determined

Sponsors & Collaborators

• University Medical Center Nijmegen

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

• Meander Medical Center

  collaborator OTHER

• Haga Hospital

  collaborator OTHER

• Klinikum Oldenburg gGmbH

  collaborator OTHER

• Jan-Willem C Alffenaar

  lead OTHER

Principal Investigators

• J GW Kosterink, PharmD, PhD · University Medical Center Groningen

• J WC Alffenaar, PharmD PhD · University Medical Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2016-11-30

Completion

2017-01-31

Countries

• Netherlands

Study Locations