- 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 risk.
- 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.