Dosing of voriconazole according to the package leaflet compared with dosing voriconazole based on measured voriconazole concentrations in blood.

• Conditions: invasive fungal infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2008-007973-19-DE
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-31
• Last Update Posted: 31 March 2014

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 < 3 days, dosed according to product brochure
5) written informed consent

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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1) allergic to voriconazole or its excipients
2) age below 18 years
3) women who are pregnant or who are of child-bearing potential and sexually active who are not practicing an effective method of birth control
4) women who are nursing

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified