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Randomized double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection (IFI) after allo hematopoietic cell transplantation (HCT).

Author(s): Wingard JR, Carter SL, Walsh TJ, Kurtzberg J, Small TN, Baden LR, Gersten ID, Mendizabal AM, Leather HL, Confer DL, Maziarz RT, Stadtmauer EA, Bolanos-Meade J, Brown J, Dipersio JF, Boeckh M, Marr KA

Affiliation(s): University of Florida, Gainesville, FL, United States;

Publication date & source: 2010-09-08, Blood., [Epub ahead of print]

IFI is a serious threat after allogeneic HCT. This multi-center, randomized, double blind trial compared fluconazole (N=295) versus voriconazole (N=305) for the prevention of IFI in the context of a structured fungal screening program. Patients undergoing myeloablative allogeneic HCT were randomized before HCT to receive study drugs for 100 days, or for 180 days in higher risk patients. Serum galactomannan (GM) was assayed twice weekly for 60 days, then at least weekly until day 100. Positive GM or suggestive signs triggered mandatory evaluation for IFI. The primary endpoint was freedom from IFI or death (fungal-free survival, FFS) at 180 days. Despite trends to fewer IFIs (7.3% vs. 11.2%, p = 0.12), Aspergillus infections (9 vs. 17, p = 0.09), and less frequent empiric antifungal therapy (24.1% vs. 30.2%, p = 0.11) with voriconazole, FFS rates (75% vs. 78%, p = 0.49) at 180 days were similar with fluconazole and voriconazole, respectively. Relapse-free and overall survival (OS) and the incidence of severe adverse events were also similar. This study demonstrates that in the context of intensive monitoring and structured empiric antifungal therapy 6 month FFS and OS did not differ in allogeneic HCT recipients given prophylactic fluconazole or voriconazole. This trial was registered at www.clinicaltrials.gov as NCT00075803.

Page last updated: 2010-10-05

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