Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)
Status:
Completed
Trial end date:
2005-04-01
Target enrollment:
Participant gender:
Summary
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.