Itraconazole oral solution for primary prophylaxis of fungal infections in patients with hematological malignancy and profound neutropenia: A randomized, double-blind, double-placebo, multicenter trial comparing itraconazole and amphotericin B

Antimicrobial Agents and Chemotherapy

Volumn 44, Issue 7, 2000, Pages 1887-1893

  Harousseau, J L ^a   Dekker, A W ^b   Stamatoullas Bastard, A ^c   Fassas, A ^d   Linkesch, W ^e   Gouveia, J ^f   De Bock, R ^g   Rovira, M ^h   Seifert, W F ⁱ   Joosen, H ⁱ   Peeters, M ⁱ   De Beule, K ⁱ  

^a HÔTEL DIEU   (France)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^c CENTRE HENRI BECQUEREL   (France)

^d G PAPANICOLAOU HOSPITAL   (Greece)

^e UNIVERSITY HOSPITAL GRAZ   (Austria)

^f HOSPITAL DOS CAPUCHOS   (Portugal)

^g MIDDELHEIM HOSPITAL   (Belgium)

^h INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

ⁱ JANSSEN RESEARCH FOUNDATION   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

AMPHOTERICIN B; ANTIFUNGAL AGENT; ANTINEOPLASTIC AGENT; CLOTRIMAZOLE; FLUCONAZOLE; ITRACONAZOLE; KETOCONAZOLE; MICONAZOLE; NYSTATIN;

ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOCYTIC LEUKEMIA; ADOLESCENT; ADULT; AGED; ANTIBIOTIC PROPHYLAXIS; ANTIFUNGAL ACTIVITY; ARTICLE; ASPERGILLOSIS; ASPERGILLUS FUMIGATUS; ASPERGILLUS TERREUS; CANCER CHEMOTHERAPY; CANDIDA ALBICANS; CANDIDA GLABRATA; CANDIDA KRUSEI; CANDIDA PARAPSILOSIS; CANDIDIASIS; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRYPTOCOCCOSIS; CRYPTOCOCCUS NEOFORMANS; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FUSARIUM; GEOTRICHOSIS; GEOTRICHUM; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYCOSIS; NEUTROPENIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; AMPHOTERICIN B; ANTIBIOTICS, ANTIFUNGAL; ANTIFUNGAL AGENTS; ASPERGILLOSIS; DOUBLE-BLIND METHOD; FEMALE; HEMATOLOGIC NEOPLASMS; HUMANS; ITRACONAZOLE; MALE; MIDDLE AGED; NEUTROPENIA;

EID: 0033919037     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/AAC.44.7.1887-1893.2000     Document Type: Article

References (18)

1. Anaissie, E. 1992. Opportunistic mycoses in the immunocompromised host: experience at a cancer center and review. Clin. Infect. Dis. 14(Suppl.1):S43-S53.
2. De Beule, K. L. 1996. Itraconazole: pharmacology, clinical experience and future development. Int. J. Antimicrob. Agents Chemother. 6:175-181.
3. Denning, D. W., J. Y. Lee, J. S. Hostetler, P. Pappas, C. A. Kauffman, D. H. Dewsnup, J. N. Galgiani, J. R. Graybill, A. M. Sugar, A. Catanzaro, H. Gallis, J. R. Perfect, B. Dockery, W. E. Dismukes, and D. A. Stevens. 1994. NIAID mycoses study group multicenter trial of oral itraconazole therapy of invasive aspergillosis. Am. J. Med. 97:135-144.
4. Gotzsche, P. C., and H. K. Johansen. 1997. Meta-analysis of prophylactic or empirical antifungal treatment in patients with cancer complicated by neutropenia. Br. Med. J. 314:1238-1244.
5. Graybill, J. R., J. Vazquez, R. O. Darouiche, R. Morhart, D. Greenspan, C. Tuazon, L. J. Wheat, J. Carey, I. Leviton, R. G. Hewitt, R. R. MacGregor, W. Valenti, M. Respredo, and B. L. Moskovitz. 1998. Randomized trial of itraconazole oral solution for oropharyngeal candidiasis in HIV/AIDS patients. Am. J. Med. 104:33-39.
6. Kelsey, S. M., J. M. Goldman, S. McCann, A. C. Newland, J. H. Scarffe, B. A. Oppenheim, and G. J. Mufti. 1999. Liposomal amphotericine (AmBisome) in the prophylaxis of fungal infections in neutropenic patients: a randomised, double-blind, placebo-controlled study. Bone Marrow Transplant. 23:163-168.
7. Lippert, H., and H. P. Lehman (ed.). 1978. SI units in medicine. Urban & Schwarzenberg, Baltimore, Md.
8. Menichetti, F., A. Del Favero, P. Martino, G. Bucaneve, A. Micozzi, D. D'Antonio, P. Ricci, M. Carotenuto, V. Liso, A. M. Nosari, T. Barbui, G. Fasola, F. Mandelli, and the GIMEMA Infection Program. 1994. Preventing fungal infection in neutropenic patients with acute leukemia: fluconazole compared with oral amphotericin B. Ann. Intern. Med. 120:913-918.
9. Menichetti, F., A. Del Favero, P. Martino, G. Bucaneve, A. Micozzi, C. Girmenia, G. Barbabietola, L. Pagano, P. Leoni, G. Specchia, A. Caiozzo, R. Raimondi, and F. Mandelli. 1999. Itraconazole oral solution as prophylaxis for fungal infections in neutropenic patients with hematologic malignancies: a randomized, placebo-controlled, double-blind, multicenter trial. Clin. Infect. Dis. 28:250-255.
10. Morgenstern, G. R., A. G. Prentice, H. G. Prentice, J. E. Ropner, S. A. Schey, and D. W. Warnock. 1999. A randomised controlled trial of itraconazole versus fluconazole for the prevention of fungal infections in patients with haematological malignancies. Br. J. Haematol. 105:901-911.
11. Phillips, P., K. De Beule, G. Frechette, S. Tchmouroff, B. Vandercam, L. Weitner, A. Hoepelman, G. Stingl, and B. Clotet. 1998. A double-blind comparison of itraconazole oral solution and fluconazole capsules for the treatment of oropharyngeal candidiasis in patients with AIDS. 26:1368-1373.
12. Prentice, A. G., D. W. Warnock, S. A. N. Johnson, M. J. Phillips, and D. A. Oliver. 1994. Multiple dose pharmacokinetics of an oral solution of itraconazole in autologous bone marrow transplant recipients. J. Antimicrob. Chemother. 34:247-252.
13. Prentice, A. G., D. W. Warnock, S. A. N. Johnson, P. C. Taylor, and D. A. Oliver. 1995. Multiple dose pharmacokinetics of an oral solution of itraconazole in patients receiving chemotherapy for acute myeloid leukaemia. J. Antimicrob. Chemother. 36:657-663.
14. Schwartz, S., G. Behre, V. Heinemann, H. Wandt, E. Schilling, M. Arning, A. Trittin, W. V. Kern, O. Boenisch, D. Bosse, K. Lenz, W. D. Ludwig, W. Hiddemann, W. Siegert, and J. Beyer. 1999. Aerosolized amphotericin B inhalations as prophylaxis of invasive aspergillus infections during prolonged neutropenia: results of a prospective randomized multicenter trial. 93:3654-3661.
15. Sheehan, D. J., C. A. Hitchcock, and C. M. Sibley. 1999. Current and emerging azole antifungal agents. Clin. Microbiol. Rev. 12:40-79.
16. Van de Velde, V. J., A. P. Van Peer, J. J. Heykants, R. J. Woestenborghs, P. Van Rooy, K. L. De Beule, and G. F. Cauwenbergh. 1996. Effect of food on the pharmacokinetics of a new hydroxypropyl-beta-cyclodextrin formulation of itraconazole. Pharmacotherapy 16:424-428.
17. Wingard, J. R., W. G. Merz, M. G. Rinaldi, T. R. Johnson, E. J. Kapp, and R. Saral. 1991. Increase in Candida krusei infection among patients with bone marrow transplantation and neutropenia treated prophylactically with fluconazole. N. Engl. J. Med. 325:1274-1277.
18. Winston, D. J., P. H. Chandrasekar, H. M. Lazarus, J. L. Goodman, J. L. Silber, H. Horowitz, R. K. Shadduck, C. S. Rosenfeld, W. G. Ho, G. H. Winston, M. Z. Islam, and D. N. Buell. 1993. Fluconazole prophylaxis of fungal infections in patients with acute leukemia. Ann. Intern. Med. 118: 495-501.