Randomized Double-blind Trial of Fluconazole vs Voriconazole for Prevention of Invasive Fungal Infection after Allo Hematopoietic Cell Transplantation
Publication Type
Journal Article
Year of Publication
2010
Authors
Wingard, J; Carter, S; Walsh, T; Kurtzberg, J; Small, T; Baden, L; Gersten, I; Mendizabal, A; Leather, H; Confer, D; Maziarz, R; Stadtmauer, E; Bolanos-Meade, J; Brown, J; DiPersio, J; Boeckh, M; Marr, K
Secondary
Blood
Volume
116
Start Page
5111
Pagination
5111-5118
Date Published
12/2010
Keywords
Adolescent; Adult; Aged; Antifungal Agents; Aspergillosis; Child; Disease-Free Survival; Double-Blind Method; Drug Monitoring; Fluconazole; Hematologic Neoplasms; Hematopoietic Stem Cell Transpl; Research NIH Extramural/Non-US Gov
Abstract
{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%
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