Study objectives To evaluate the safety of the echinocandin anidulafungin for prophylaxis or
treatment of invasive fungal infections (IFI) in hematologic patients.
Study design, Study conduct period Prospective, open label, phase II, one arm, single centre
study October 2009 - September 2010
Study population Twenty adult patients (≥ 18 years) with a hematologic disorder and an
indication for antifungal prophylaxis or therapy, but a relative contraindication for azoles
or polyenes due to hepatic and renal dysfunction respectively
Methods and Main Out-come Variables Main Outcome Parameter Safety: Adverse events and changes
of important laboratory parameters with clinical impact will be reported.
Secondary Outcome Parameter Efficacy: In therapeutically use the outcome will be categorized
into success or failure. For patients receiving anidulafungin as prophylaxis the number and
rate of breakthrough infections will be documented.
Risk assessment Treatment related adverse effects as reported in the approved physician
prescribing information (usually mild and with an incidence of < 5%). Treatment failure due
to resistant pathogens.
Expected benefit from this study IFI is a major cause of death among hematological patients,
especially those undergoing high dose chemotherapy. It is conceivable that anidulafungin is a
new treatment option for patients in whom azoles or polyenes are relatively contraindicated.