Multicenter randomized trial of intra venous/oral itraconazole vs. intra venous/oral fluconazole for long-term antifungal prophylaxis in allogeneic bone marrow transplant patients

D. J. Winston, R. 7: Maziarz, I? R. Chandrasekar, R. M. Lazarus, M. Goldman, G. Leitz, M. C. Territo

Author address: 

*UCLA Medical Center, Los Angeles, CA; University of Oregon, Portland OR; Wayne State University, Detroit, MI; Case Western University, Cleveland, OR; Indiana University, Indianapolis, IN; Ortllo Biotech, Raritan, NJ, USA


Invasive fungal infections are a leading cause of morbidity and mortality in allogeneic bone marrow transplant (BMT) patients both early and late after transplant. In this multicenter trial, allogeneic BMT patients were randomized to receive long-term antifungal prophylaxis with either itraconazole (ITRA) (200 rng IV ql2hrs for 2 days followed by 200 mg IV q24hrs or 200 mg oral solution ql2hrs) or fluconazole (FLU) (400 mg IV or orally q24hrs.) from day 1 until day 100 after BMT. Each study drug was given IV for the first 14 days followed by oral therapy. Patients unable to take oral therapy returned to IV study drug. 71 patients received ITRA; 67 patients received FLU. Proven invasive fungal infections occurred in 6/71 (9%) ITRA patients and 17/67 (25%) FLU patients within 180 days after BMT (P=O.Ol). Proven superficial fungal infections occurred in 3/71(4%) ITRA patients and 2/67 (3%) FLU patients. In a multivariate regression analysis using factors known to affect the risk of invasive fungal infection after BMT, prophylaxis with ITRA was still associated with a lower risk for invasive fungal infection (p=O.O2) caused by either yeasts or molds. Death from fungal infection occurred in 6/71 (9%) ITRA patients and 12167 (18%) FLU patients (p=O.13). Both ITRA and FLU were generally well-tolerated. Gastrointestinal adverse events (nausea, vomiting, diarrhea, abdominal pain) were more frequent in ITRA patients (17/71 or 24% vs. 6167 or 9%, p=O.O2). There was no appreciable hepatotoxicity with either ITRA or FLU. These results suggest that IV/oral ITRA may be more effective than IV/oral FLU for long-term prophylaxis of early and late invasive fungal infections after allogeneic BMT.

abstract No: 


Full conference title: 

12th International Symposium on Infections in the Immunocompromised Host
    • ISIIH 12th