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About
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.
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Volunteers
Inclusion criteria
Exclusion criteria
Known proven, probable or possible invasive fungal infection at randomization or in patient history
Computed tomography (CT) with any signs of a fungal infection according to the European Organisation for the Research and Treatment of Cancer (EORTC)/Mycosis Study Group (MSG) criteria, i.e. with any infiltrate (Ascioglu, et al 2002)
Any current fever unless explained by non-infectious causes
Antibacterial prophylaxis other than TMP/SMX
Liver function test [LFT] (AST/ALT/bilirubin) more than 3x the upper normal limit
Subjects who are receiving and cannot discontinue one of the following drugs at least 24 hours prior to randomization:
Subjects who have received the following drugs within 14 days prior to randomization: potent inducers of hepatic enzymes that will reduce voriconazole levels (e.g. rifampicin, carbamazepine and barbiturates)
Concomitant therapy with absorbable antifungals
Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause
Known hypersensitivity or other contraindication to voriconazole
Patient is unwilling or unable to comply with the protocol.
Diseases or disabilities preventing the patient from participating in the trial
Females of childbearing potential without negative serum pregnancy test at baseline or within 72 hours prior to start of study drug
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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