Anidulafungin in patients with hematologic malignancies - An open-label, prospective study to evaluate the safety profile at prophylactic and therapeutic dosages - ECALTA
- Conditions
- hematologic malignancies with risk for or active invasive fungal infection
- Registration Number
- EUCTR2009-014527-23-AT
- Lead Sponsor
- KH der Elisabethinen Linz GmbH, I. Interne Abteilung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Adult patients (>17 years) with a hematologic disorder AND an indication for IFI prophylaxis or therapy, but a relative contraindication for azoles or polygenes due to hepatic or renal dysfunction, are scheduled to receive anidulafungin for one of the folowing specific indications:
need for primary antifungal prophylaxis in patients with AML/MDS during induction, reinduction or consolidation chemotherapy OR after allogenic HSCT with GvHD
need for secondary antifungal prophylaxis in patients with a history of a proven or probable invasive fungal infection who are expected to become neutropenic during induction, reinduction or consolidation chemotherapy
indication for treatment of proven, probable or possible fungal infection
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
absence of written informed consent
female patients who are pregnant or lactating
use of anidulafungin within 30 days prior to study
known hypersensitivity to anidulafungin
proven IFI with pathogen of known resistance to echinocandines
life expectancy less than 1 month
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