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; Pagano, Livio; Leoni, Pietro; Specchia, Giorgina; Caiozzo, Alessandro; Raimondi, Roberto; Mandelli, Franco; the GIMEMA Infection Program

doi:10.1086/515129

Cited by 244Antifungal resistance and susceptibilityNeutropenia and Cancer InfectionsFungal Infections and Studies

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, Pagano, Livio +6 more·1999·Clinical Infectious Diseases

DOI 10.1086/515129

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Abstract

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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The bioavailability of current oral formulations of itraconazole is unpredictable.
“the bioavailability of the current oral formulations of itraconazole (including the cyclodextrin solution) is unpredictable [145,146].”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [146]

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Authors: Menichetti, F., Del Favero, A., Martino, P., Bucaneve, G., Micozzi, A., Girmenia, C., Barbabietola, G., Pagano, L., Leoni, P., Specchia, G., Caiozzo, A., Raimondi, R., Mandelli, F., & Program, T. G. I.
Affiliations: University of Perugia (IT)
ORCID: Bucaneve, Giampaolo
Micozzi, Alessandra
Girmenia, Corrado
Pagano, Livio
Specchia, Giorgina
Raimondi, Roberto
Venue: Clinical Infectious Diseases
Publisher: Oxford University Press (OUP)
Published: 1999-02
Volume: 28
Issue: 2
Pages: 250-255
ISSN: 1058-4838 (ISSN-L)
1537-6591
DOI: 10.1086/515129
OpenAlex: W2142418809
Cited by: 244
References: 12
Citations by year: 2025: 2 · 2024: 1 · 2022: 1 · 2021: 6 · 2020: 2 · 2019: 2 · 2018: 6 · 2016: 4 · 2015: 7 · 2014: 6 · 2013: 6 · 2012: 6
FWCI: 19.39
Type: journal article
Language: en
Open access: closed
Locations: Clinical Infectious Diseases (publishedVersion)
PubMed (publishedVersion)
CINECA IRIS Institutial research information system (University of Pisa) (submittedVersion)
Florence Research (University of Florence) (submittedVersion)
IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
Institutional Research Information System University of Ferrara (University of Ferrara) (submittedVersion)
Topics: Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
Health Sciences › Medicine › Oncology › Neutropenia and Cancer Infections
Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
Keywords: itraconazole, oral solution, antifungal prophylaxis, fungal infection, neutropenia, hematologic malignancies, candidemia, Candida, aspergillosis, Aspergillus, deep fungal infection, drug safety
MeSH terms: Administration, Oral, Adolescent, Adult, Aged, Antifungal Agents, Double-Blind Method, Female, Humans, Male, Middle Aged, Mycoses, Neutropenia, Patient Compliance, Itraconazole, Hematologic Neoplasms

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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

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