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

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

Clinical infectious diseases, 1999-02, Vol.28 (2), p.250-255 [Periódico revisado por pares]

Chicago, IL: The University of Chicago Press

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Título:
Itraconazole Oral Solution as Prophylaxis for Fungal Infections in Neutropenic Patients with Hematologic Malignancies: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial
Autor: Menichetti, Francesco ; Del Favero, Albano ; Martino, Piero ; Bucaneve, Giampaolo ; Micozzi, Alessandra ; Girmenia, Corrado ; Barbabietola, Giuliana ; Pagan, Livio ; Leoni, Pietro ; Specchia, Giorgina ; Caiozzo, Alessandro ; Raimondi, Roberto ; Mandelli, Franco
Assuntos: Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antifungal agents ; Antifungals ; Aspergillus ; Biological and medical sciences ; Bone marrow ; Clinical Articles ; Fungal infections ; Hematologic neoplasms ; Infections ; Leukemia ; Medical sciences ; Mortality ; Neutropenia ; Pharmacology. Drug treatments ; Placebos
É parte de: Clinical infectious diseases, 1999-02, Vol.28 (2), p.250-255
Notas: ark:/67375/HXZ-DXTXX49H-S
istex:F7C365277F8A037B3E23651B366D15545A3A794A
Descrição: 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.
Editor: Chicago, IL: The University of Chicago Press
Idioma: Inglês

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

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

Chicago, IL: The University of Chicago Press

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