Itraconazole oral solution as prophylaxis for fungal infections in neutropenic patients with hematologic malignancies: A randomized, placebo-controlled, double-blind, multicenter trial

被引:180
作者
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
机构
[1] Univ Perugia, Ist Malattie Infett, I-06100 Perugia, Italy
[2] Univ Perugia, Ist Clin Med 1, I-06100 Perugia, Italy
[3] Univ La Sapienza, Cattedra Ematol, Rome, Italy
[4] Univ Cattolica, Ist Semeiot Med, Rome, Italy
[5] Univ Ancona, Ist Ematol, Ancona, Italy
[6] Univ Bari, Cattedra Ematol, Bari, Italy
[7] Univ Palermo, Cattedra Ematol, Palermo, Italy
[8] Osped S Bortolo, Div Ematol, Vicenza, Italy
关键词
D O I
10.1086/515129
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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.
引用
收藏
页码:250 / 255
页数:6
相关论文
共 18 条
[1]   PREVENTION OF BACTERIAL-INFECTION IN NEUTROPENIC PATIENTS WITH HEMATOLOGIC MALIGNANCIES - A RANDOMIZED, MULTICENTER TRIAL COMPARING NORFLOXACIN WITH CIPROFLOXACIN [J].
DELFAVERO, A .
ANNALS OF INTERNAL MEDICINE, 1991, 115 (01) :7-12
[2]  
*EORTC GIMEMA, 1990, BLOOD S1, V76, P340
[3]   A CONTROLLED TRIAL OF FLUCONAZOLE TO PREVENT FUNGAL-INFECTIONS IN PATIENTS UNDERGOING BONE-MARROW TRANSPLANTATION [J].
GOODMAN, JL ;
WINSTON, DJ ;
GREENFIELD, RA ;
CHANDRASEKAR, PH ;
FOX, B ;
KAIZER, H ;
SHADDUCK, RK ;
SHEA, TC ;
STIFF, P ;
FRIEDMAN, DJ ;
POWDERLY, WG ;
SILBER, JL ;
HOROWITZ, H ;
LICHTIN, A ;
WOLFF, SN ;
MANGAN, KF ;
SILVER, SM ;
WEISDORF, D ;
HO, WG ;
GILBERT, G ;
BUELL, D .
NEW ENGLAND JOURNAL OF MEDICINE, 1992, 326 (13) :845-851
[4]   Meta-analysis of prophylactic or empirical antifungal treatment versus placebo or no treatment in patients with cancer complicated by neutropenia [J].
Gotzsche, PC ;
Johansen, HK .
BMJ-BRITISH MEDICAL JOURNAL, 1997, 314 (7089) :1238-1244
[5]   PREVENTING FUNGAL INFECTION IN NEUTROPENIC PATIENTS WITH ACUTE-LEUKEMIA - FLUCONAZOLE COMPARED WITH ORAL AMPHOTERICIN-B [J].
MENICHETTI, F ;
DELFAVERO, A ;
MARTINO, P ;
BUCANEVE, G ;
MICOZZI, A ;
DANTONIO, D ;
RICCI, P ;
CAROTENUTO, M ;
LISO, V ;
NOSARI, AM ;
BARBUI, T ;
FASOLA, G ;
MANDELLI, F ;
MONTILLO, M ;
BARBABIETOLA, G ;
DINOTA, A ;
PAGANO, L ;
JACOPINO, P ;
ISABELLA, N ;
FONTANA, R ;
LANDONIO, G ;
BROCCIA, G ;
CUDILLO, L ;
DIFAZIO, S ;
PACILLI, L ;
MONACO, M ;
CARELLA, AM ;
CHIERICHINI, A ;
QUINTINI, G ;
GABBAS, A ;
CITARELLA, P ;
DALLASTA, A ;
RONCONI, F ;
DORE, F ;
GALIENI, P .
ANNALS OF INTERNAL MEDICINE, 1994, 120 (11) :913-918
[6]  
MORGENSTERN GR, 1996, 36 INT C ANT AG CHEM, P286
[7]   ORAL KETOCONAZOLE PROPHYLAXIS FOR CANDIDA-INFECTIONS DURING INDUCTION THERAPY FOR ACUTE-LEUKEMIA IN ADULTS - MORE BACTEREMIAS [J].
PALMBLAD, J ;
LONNQVIST, B ;
CARLSSON, B ;
GRIMFORS, G ;
JARNMARK, M ;
LERNER, R ;
LJUNGMAN, P ;
NYSTROMROSANDER, C ;
PETRINI, B ;
OBERG, G .
JOURNAL OF INTERNAL MEDICINE, 1992, 231 (04) :363-370
[8]   MULTIPLE-DOSE PHARMACOKINETICS OF AN ORAL SOLUTION OF ITRACONAZOLE IN AUTOLOGOUS BONE-MARROW TRANSPLANT RECIPIENTS [J].
PRENTICE, AG ;
WARNOCK, DW ;
JOHNSON, SAN ;
PHILLIPS, MJ ;
OLIVER, DA .
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 1994, 34 (02) :247-252
[9]   MULTIPLE-DOSE PHARMACOKINETICS OF AN ORAL SOLUTION OF ITRACONAZOLE IN PATIENTS RECEIVING CHEMOTHERAPY FOR ACUTE MYELOID-LEUKEMIA [J].
PRENTICE, AG ;
WARNOCK, DW ;
JOHNSON, SAN ;
TAYLOR, PC ;
OLIVER, DA .
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 1995, 36 (04) :657-663
[10]   EFFECT OF PROPHYLACTIC FLUCONAZOLE ON THE FREQUENCY OF FUNGAL-INFECTIONS, AMPHOTERICIN-B USE, AND HEALTH-CARE CASTS IN PATIENTS UNDERGOING INTENSIVE CHEMOTHERAPY FOR HEMATOLOGIC NEOPLASIAS [J].
SCHAFFNER, A ;
SCHAFFNER, M .
JOURNAL OF INFECTIOUS DISEASES, 1995, 172 (04) :1035-1041