A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, COMPARATIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF NYSTATIN AND AMPHOTERICIN B FOR EMPIRIC ANTIFUNGAL TREATMENT IN NEUTROPENIC PATIENTS

Inclusion Criteria

DISEASE CHARACTERISTICS: Persistent febrile neutropenia associated with 1 of the following
within 3 months prior to entry: Cytotoxic chemotherapy Bone marrow transplantation
Neutropenia defined as either: ANC no greater than 500/mm3 ANC no greater than 1,000/mm3
and expected to decrease to 500/mm3 or less within 2 days after entry Persistent
continuous or spiking fever of at least 38 C No association with administration of
pyrogenic substances No response to at least 72 hours of empiric, broad-spectrum
antibacterial therapy No microbiologically documented source of infection At least 30 days
since documented invasive fungal infection

PATIENT CHARACTERISTICS: Age: 2 and over Performance status: Not specified Life
expectancy: At least 28 days Hematopoietic: Not specified Hepatic: No grade 2 or greater
hepatic impairment Renal: No grade 2 or greater renal impairment No peritoneal dialysis or
hemodialysis Other: No history of severe allergic reaction to polyene antifungal agent No
pregnant or nursing women Negative pregnancy test required of fertile women Effective
contraception required of fertile women during and for 3 months after study

PRIOR CONCURRENT THERAPY: At least 2 weeks since polyene antifungal therapy Concurrent
oral prophylactic antifungal therapy with an azole antifungal agent (e.g., fluconazole,
itraconazole) allowed if patient remains febrile No concurrent azole therapy At least 30
days since other investigational drug or device except investigational formulation of
amphotericin B