Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)
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|ClinicalTrials.gov Identifier: NCT00044486|
Recruitment Status : Completed
First Posted : September 4, 2002
Last Update Posted : March 10, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myelocytic, Acute Myelodysplastic Syndromes Neutropenia||Drug: Posaconazole oral suspension||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||602 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||April 2005|