The purpose of the study is to determine whether voriconazole is as effective as antifungal prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (AML). Hypothesis: Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until day 21 after the start of induction chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
150
Klinikum der Universität Köln
Cologne, Germany
Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, Germany
Universitätsklinikum Mannheim, Universität Heidelberg
Heidelberg, Germany
To determine the incidence of lung infiltrates until day 21 among patients undergoing the first induction chemotherapy for acute myelogenous leukemia who are randomized to prophylactic voriconazole or placebo
To determine and compare between study arms the: incidence of fever and other signs of infection
incidence and type of documented bacteremia
rate of patients with systemic open-label antifungal therapy
time to initiation of systemic open-label antifungal therapy
duration of absolute neutrophil count < 500/µl
rate and type of proven, probable and possible breakthrough invasive fungal infections
rate of patients with fever of unknown origin
incidence and severity of adverse events
trough voriconazole plasma level after day 8 of study treatment
direct costs of systemic antibiotics, antifungals and antivirals and diagnostic imaging
overall costs in terms of the diagnosis related groups applied to the study patients
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