Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal Disease
NCT01249820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2020-12-08
Summary
The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease.
Conditions
- Leukemia
- Myelodysplastic Syndrome
- Leukemia, Myeloid, Acute
Interventions
- DRUG
-
anidulafungin 200 mg q48h
Day 1-15: anidulafungin 200 mg q48h IV maintenance dose (8 dosages)
- DRUG
-
anidulafungin 300 mg q72h
Day 1-13: anidulafungin 300 mg q72h IV maintenance dose (5 dosages)
Sponsors & Collaborators
-
Radboud University Medical Center
lead OTHER
Principal Investigators
-
R Brüggemann, PharmD · Radboud University Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2013-01-31
- Completion
- 2013-01-31
Countries
- Netherlands
Study Locations
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