hematologic malignancies with risk for or active invasive fungal infection
Conditions
Interventions
Trade Name: ECALTA
Product Name: anidulafungin
Pharmaceutical Form: Powder and solvent for solution for infusion
Sponsors
KH der Elisabethinen Linz GmbH, I. Interne Abteilung
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the safety of the echinocandine anidulafungin for prophylaxis or treatment of invasive fungal infections (IFI) in hematologic patients;Secondary Objective: pharmacokinetics and efficacy;Primary end point(s): Safety: for all patients who will receive anidulafungin without regard to indication the incidence of (serious) adverse events and changes of important laboratory parameters with clinical impact will be reported | — |
Countries
Austria
Outcome results
None listed