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

2014-08-27 03:41:01 | BioPortfolio

Summary

Patients who undergo chemotherapy for leukemia will recieve an antifungal intravenously for prophylaxis of fungal infections. The study investigates the safet and tolerability of two different dosages, the efficacy in prevention of fungal diseases and the blood levels(pharmacokinetics)of the antifungal drug.

Description

Patients with Acute Myeloid Leukemia who undergo agressive chemotherapy are due to immunesuppression 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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Acute Myeloid Leukemia

Intervention

BAL8557

Location

University Cologne
Bremen
Germany
50937

Status

Completed

Source

Basilea Pharmaceutica

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:01-0400

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