Myelodysplastic Syndromes Clinical Trial
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
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.
This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis if IFI in high-risk subjects with prolonged profound neutropenia. The primary objective is to assess the efficacy of SCH 56592 vs fluconazole and itraconazole in preventing proven or probable IFI during neutropenic episodes. ;
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