To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.
To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment. Determine and compare the following parameters for the two treatment arms: * Safety and tolerability * Survival rates and the rates of infection relapse at 4 weeks Post Treatment. * Survival rate at 12 weeks after study entry. * Time to favorable overall response and time to End of Treatment for patients with favorable overall response. * Cumulative dose of study drug given through End of Treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
800
Evaluate two regimens determined by overall response rates at end of tx.
Compare Safety/tolerability; survival rates/rates of infection relapse at 4 wks post tx; survival rate at 12 wks after study entry; TOVR; time to end of tx for patients w/favorable overall response;cumulative dose
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