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, Corrado Girmenia, Giuliana Barbabietola, Livio Pagano, Pietro Leoni, Giorgina Specchia, Alessandro Caiozzo, Roberto Raimondi, Franco Mandelli, N. Cascavilla, G. Rigolin, G. Lambertenghi Deliliers, B. Martino, A. Peta, P. Ricci, R. Fanci & 25 others W. De Plano, P. Sivera, V. Zagonel, C. Caramatti, R. Invernizzi, M. Buelli, C. Bernasconi, A. Carella, E. Damasio, R. De Biasi, A. Chierichini, P. Galieni, M. Grasso, P. Jacopino, E. Morra, A. Porcellini, L. Resegotti, F. Ricciuti, M. Picardi, F. Ronconi, R. Cimino, R. Cimino, C. Ferrandina, A. Gabbas, V. Mettivier

Research output: Contribution to journalArticle

219 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)250-255
Number of pages6
JournalClinical Infectious Diseases
Volume28
Issue number2
Publication statusPublished - 1999

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Itraconazole
Mycoses
Hematologic Neoplasms
Multicenter Studies
Placebos
Confidence Intervals
Candida
Fungemia
Candidemia
Aspergillus
Infection
Drug-Related Side Effects and Adverse Reactions
Safety

ASJC Scopus subject areas

  • Immunology

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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; Pagano, Livio; Leoni, Pietro; Specchia, Giorgina; Caiozzo, Alessandro; Raimondi, Roberto; Mandelli, Franco; Cascavilla, N.; Rigolin, G.; Deliliers, G. Lambertenghi; Martino, B.; Peta, A.; Ricci, P.; Fanci, R.; De Plano, W.; Sivera, P.; Zagonel, V.; Caramatti, C.; Invernizzi, R.; Buelli, M.; Bernasconi, C.; Carella, A.; Damasio, E.; De Biasi, R.; Chierichini, A.; Galieni, P.; Grasso, M.; Jacopino, P.; Morra, E.; Porcellini, A.; Resegotti, L.; Ricciuti, F.; Picardi, M.; Ronconi, F.; Cimino, R.; Cimino, R.; Ferrandina, C.; Gabbas, A.; Mettivier, V.

In: Clinical Infectious Diseases, Vol. 28, No. 2, 1999, p. 250-255.

Research output: Contribution to journalArticle

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, Cascavilla, N, Rigolin, G, Deliliers, GL, Martino, B, Peta, A, Ricci, P, Fanci, R, De Plano, W, Sivera, P, Zagonel, V, Caramatti, C, Invernizzi, R, Buelli, M, Bernasconi, C, Carella, A, Damasio, E, De Biasi, R, Chierichini, A, Galieni, P, Grasso, M, Jacopino, P, Morra, E, Porcellini, A, Resegotti, L, Ricciuti, F, Picardi, M, Ronconi, F, Cimino, R, Cimino, R, Ferrandina, C, Gabbas, A & Mettivier, V 1999, 'Itraconazole oral solution as prophylaxis for fungal infections in neutropenic patients with hematologic malignancies: A randomized, placebo- controlled, double-blind, multicenter trial', Clinical Infectious Diseases, vol. 28, no. 2, pp. 250-255.
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 ; Cascavilla, N. ; Rigolin, G. ; Deliliers, G. Lambertenghi ; Martino, B. ; Peta, A. ; Ricci, P. ; Fanci, R. ; De Plano, W. ; Sivera, P. ; Zagonel, V. ; Caramatti, C. ; Invernizzi, R. ; Buelli, M. ; Bernasconi, C. ; Carella, A. ; Damasio, E. ; De Biasi, R. ; Chierichini, A. ; Galieni, P. ; Grasso, M. ; Jacopino, P. ; Morra, E. ; Porcellini, A. ; Resegotti, L. ; Ricciuti, F. ; Picardi, M. ; Ronconi, F. ; Cimino, R. ; Cimino, R. ; Ferrandina, C. ; Gabbas, A. ; Mettivier, V. / Itraconazole oral solution as prophylaxis for fungal infections in neutropenic patients with hematologic malignancies : A randomized, placebo- controlled, double-blind, multicenter trial. In: Clinical Infectious Diseases. 1999 ; Vol. 28, No. 2. pp. 250-255.
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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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T2 - A randomized, placebo- controlled, double-blind, multicenter trial

AU - Menichetti, Francesco

AU - Del Favero, Albano

AU - Martino, Piero

AU - Bucaneve, Giampaolo

AU - Micozzi, Alessandra

AU - Girmenia, Corrado

AU - Barbabietola, Giuliana

AU - Pagano, Livio

AU - Leoni, Pietro

AU - Specchia, Giorgina

AU - Caiozzo, Alessandro

AU - Raimondi, Roberto

AU - Mandelli, Franco

AU - Cascavilla, N.

AU - Rigolin, G.

AU - Deliliers, G. Lambertenghi

AU - Martino, B.

AU - Peta, A.

AU - Ricci, P.

AU - Fanci, R.

AU - De Plano, W.

AU - Sivera, P.

AU - Zagonel, V.

AU - Caramatti, C.

AU - Invernizzi, R.

AU - Buelli, M.

AU - Bernasconi, C.

AU - Carella, A.

AU - Damasio, E.

AU - De Biasi, R.

AU - Chierichini, A.

AU - Galieni, P.

AU - Grasso, M.

AU - Jacopino, P.

AU - Morra, E.

AU - Porcellini, A.

AU - Resegotti, L.

AU - Ricciuti, F.

AU - Picardi, M.

AU - Ronconi, F.

AU - Cimino, R.

AU - Cimino, R.

AU - Ferrandina, C.

AU - Gabbas, A.

AU - Mettivier, V.

PY - 1999

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