Pharmacologic optimization of voriconazole - a prospective clustered group-randomized cross-over trial of therapeutic drug monitoring

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-007973-19-NL

Enrollment

192

Registered

2009-01-22

Start date

2009-04-09

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The objective of this prospective stratified cluster randomized cross-over trial is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved outcome in patient with haematological malignancies (efficacy and safety) and is more cost-effective compared to the current standard of care.

Interventions

Trade Name: Vfend Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) are at least 18 years of age 2) have received chemotherapy for haematological malignancies or have received a hematopoietic stem cell transplant 3) proven, probable or possible invasive fungal disease according to the EORTC/MSG criteria 4) treatment with voriconazole Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) allergic to voriconazole or its excipients 2) age below 18 years

Design outcomes

Primary

Measure	Time frame
Main Objective: 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). ;Secondary Objective: The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) is more cost-effective compared to the current standard of care. ;Primary end point(s): The primary endpoint is a reduction in risk of failure on day 28 of treatment with voriconazole. This failure is based on the categorized global response 1) Complete Response: resolution of all clinical signs and symptoms and more than 90 percent of the IA related lesions that were visible on radiographic studies at baseline; 2) Partial Response: Clinical improvement and greater than 50 percent improvement in radiological findings present at baseline; 3) Stable: No change from baseline, or an improvement of less than 50 percent in radiological findings; 4) Failure: Worsening disease.	—

Measure

Time frame

Main Objective: 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). ;Secondary Objective: The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) is more cost-effective compared to the current standard of care. ;Primary end point(s): The primary endpoint is a reduction in risk of failure on day 28 of treatment with voriconazole. This failure is based on the categorized global response 1) Complete Response: resolution of all clinical signs and symptoms and more than 90 percent of the IA related lesions that were visible on radiographic studies at baseline; 2) Partial Response: Clinical improvement and greater than 50 percent improvement in radiological findings present at baseline; 3) Stable: No change from baseline, or an improvement of less than 50 percent in radiological findings; 4) Failure: Worsening disease.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026