At a glance
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Phase III Clinical Trial of Oral Posaconazole 3 Times/Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) for Prevention of Invasive Fungal Infections In Patients With Hematologic Malignancies & Hematopoietic Stem Cell Transplant
In Brief
A Phase 3 clinical trial evaluating Posaconazole and ABLC for Invasive Fungal Infections and Hematologic Malignancies. Completed, enrolled 46 participants across 1 site.
Detailed Summary
The objective of this study is to compare the safety and efficacy of ABLC versus oral Posaconazole in the prevention of invasive fungal infections in high risk patients with hematologic malignancies or hematopoietic stem cell transplant. Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal infections associated with ABLC or Posaconazole prophylaxis. Secondary objective will be to compare the cost effectiveness of these two prophylactic regimens.
Study Details
Timeline
Interventions
200 mg three times daily by mouth up to 6 weeks (Days 1-42)
7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)