Spots Global Cancer Trial Database for Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy

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Trial Identification

Brief Title: Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy

Official Title: Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia

Study ID: NCT00413439

Conditions

Acute Myeloid Leukemia

Interventions

Isavuconazole

Study Description

Brief Summary: Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal diseases.

Detailed Description: Patients with Acute Myeloid Leukemia who undergo aggressive chemotherapy are due to immunosuppression susceptible to infections, including fungal infections. As the failure rate in the treatment of invasive fungal infections is high, prophylaxis is frequently recommended. This open label study investigates the safety and tolerability of two different dosages of a water soluble azole antifungal, as well as the efficacy in prevention of invasive fungal infections and pharmacokinetic data.