Pharmacologic optimization of voriconazole - a prospective clustered group-randomized cross-over trial of therapeutic drug monitoring
- 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.
- Registration Number
- EUCTR2008-007973-19-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 192
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
1) allergic to voriconazole or its excipients
2) age below 18 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method