Invasive Aspergillosis Clinical Trial
Official title:
Study of the Safety and Efficacy of AmBisome Loading Dose Regimen Vs. a Standard AmBisome Regimen for Initial Treatment of Invasive Aspergillosis and Other Filamentous Fungal Infections in Immunocompromised Patients
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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