Journal Article

Itraconazole Oral Solution as Prophylaxis for Fungal Infections in Neutropenic Patients with Hematologic Malignancies: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial

Francesco Menichetti, Albano Del Favero, Piero Martino, Giampaolo Bucaneve, Alessandra Micozzi, Giampaolo Bucaneve, Alessandra Micozzi, Corrado Girmenia, Giuliana Barbabietola, Livio Pagan, Pietro Leoni, Giorgina Specchia, Alessandro Caiozzo, Roberto Raimondi and Franco Mandelli

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 28, issue 2, pages 250-255
Published in print February 1999 | ISSN: 1058-4838
Published online February 1999 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/515129
Itraconazole Oral Solution as Prophylaxis for Fungal Infections in Neutropenic Patients with Hematologic Malignancies: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial

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To evaluate the efficacy and safety of itraconazole oral solution for preventing fungal infections, a randomized, placebo-controlled, double-blind, multicenter trial was conducted: 405 neutropenic patients with hematologic malignancies were randomly assigned to receive either itraconazole, 2.5 mg/kg every 12 hours (201 patients), or placebo (204 patients). Proven and suspected deep fungal infection occurred in 24% of itraconazole recipients and in 33% of placebo recipients, a difference of 9 percentage points (95% confidence interval [CI], 0.6% to 22.5%; P = .035). Fungemia due to Candida species was documented in 0.5% of itraconazole recipients and in 4% of placebo recipients, a difference of 3.5 percentage points (95% CI, 0.5% to 6%; P = .01). Deaths due to candidemia occurred in none of the itraconazole recipients compared with 4 placebo recipients, a difference of 2 percentage points (95% CI, 0.05% to 4%; P = .06). Aspergillus infection was documented in four itraconazole recipients (one death) and one placebo recipient (one death). Side effects causing drug interruption occurred in 18% of itraconazole recipients and 13% of placebo recipients. Itraconazole oral solution was well-tolerated and effectively prevented proven and suspected deep fungal infection as well as systemic infection and death due to Candida species.

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Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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