Journal Article

A Double-Blind, Randomized, Placebo-Controlled Trial of Itraconazole Capsules as Antifungal Prophylaxis for Neutropenic Patients

Marcio Nucci, Irene Biasoli, Tiyomi Akiti, Fernanda Silveira, Cristiana Solza, Gloria Barreiros, Nelson Spector, Andrea Derossi and Wolmar Pulcheri

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 30, issue 2, pages 300-305
Published in print February 2000 | ISSN: 1058-4838
Published online February 2000 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/313654
A Double-Blind, Randomized, Placebo-Controlled Trial of Itraconazole Capsules as Antifungal Prophylaxis for Neutropenic Patients

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To evaluate the efficacy of itraconazole capsules in prophylaxis for fungal infections in neutropenic patients, we conducted a prospective, double-blind, placebo-controlled, randomized trial. Patients with hematologic malignancies or those who received autologous bone marrow transplants were assigned either a regimen of itraconazole (100 mg orally twice daily; n = 104) or of placebo (n = 106). Overall, fungal infections (superficial or systemic) occurred more frequently in the placebo group (15% vs. 6%; P = .03). There were no differences in the empirical use of amphotericin B or systemic fungal infections. Among patients with neutropenia that was profound (<100 neutrophils/mm3) and prolonged (for at least 7 days), those receiving itraconazole used less empirical amphotericin B (22% vs. 61%; P = .0001) and developed fewer systemic fungal infections (6% vs. 19%; P = .04). For patients with profound and prolonged neutropenia, itraconazole capsules at the dosage of 100 mg every 12 h reduce the frequency of systemic fungal infections and the use of empirical amphotericin B.

Journal Article.  4209 words.  Illustrated.

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

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