Randomized Double-blind Trial of Fluconazole vs Voriconazole for Prevention of Invasive Fungal Infection after Allo Hematopoietic Cell Transplantation
12/2010
Journal Article
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
Pagination:
5111-5118
URL:
http://www.ncbi.nlm.nih.gov/pubmed/20826719
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%
