Status:
COMPLETED
Pharmacologic Optimization of Voriconazole
Lead Sponsor:
Jan-Willem C Alffenaar
Collaborating Sponsors:
University Medical Center Nijmegen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Invasive Fungal Infection
Hematological Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Patients with haematological malignancies and chemotherapy-induced prolonged neutropenia are at risk for severe bacterial and fungal infections. These opportunistic infections can result in prolonged ...
Eligibility Criteria
Inclusion
- are at least 18 years of age
- have received chemotherapy for haematological malignancies or have received a hematopoietic stem cell transplant
- proven, probable or possible invasive fungal disease according to the EORTC/MSG criteria
- treatment with voriconazole
Exclusion
- allergic to voriconazole or its excipients
- age below 18 years
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00893555
Start Date
April 1 2009
End Date
January 1 2017
Last Update
January 12 2017
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9713GZ