King of Prussia,
The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients
treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the
safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in
treated patients located in the United States, Europe, and South Africa.
- Diagnosis of definite IA outside the pulmonary system or definite or probable
- Life expectancy: greater than 72 hours
- Pregnant female
- Hypersensitivity to anidulafungin or echinocandin therapy
- Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
- Hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome
unless, in the opinion of the investigator, the benefit of therapy outweighs the
- Aspergilloma-in the absence of invasive disease
- Abnormal blood chemistries:
Bilirubin > 3 times the upper limit of normal; AST (aspartate aminotransferase) or ALT
(alanine aminotransferase)> 5 times the upper limit of normal
- Greater than five days of therapeutic doses of systemic therapy for the current
Aspergillus-associated condition or a cumulative dose of more than 5 mg/Kg of
amphotericin, more than 25 mg/Kg of a lipid formulation of amphotericin, or more than
2g of itraconazole for the current condition. Prophylactic use of azoles or
amphotericin is acceptable.
- Less than 4 weeks since prior participation in an investigational drug or device
study, with the exception of cytotoxic, antiretroviral agents and therapies for
AIDS-related opportunistic infections.