Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)
This trial is in high risk patients to determine the safety and efficacy of posaconazole vs. fluconazole in the prophylaxis against development of invasive fungal infections.
Profound, prolonged neutropenia (Absolute neutrophil count<500 cells/cubic mm for at least 7 days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic syndrome.
Treatment Duration: maximum of 12 weeks Follow-Up 2 months. Endpoints: incidence of proven or probable IFI according to EORTC/MSG criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review.
|Leukemia, Myelocytic, Acute Myelodysplastic Syndromes Neutropenia||Drug: Posaconazole oral suspension||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||A Randomized Controlled Trial of Posaconazole (SCH 56592) vs. Standard Azole Therapy for the Prevention of Invasive Fungal Infections Among High-Risk Neutropenic Patients|
|Study Start Date:||July 2002|
|Study Completion Date:||April 2005|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|