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Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation.

Publication ,  Journal Article
Wingard, JR; Carter, SL; Walsh, TJ; Kurtzberg, J; Small, TN; Baden, LR; Gersten, ID; Mendizabal, AM; Leather, HL; Confer, DL; Maziarz, RT ...
Published in: Blood
December 9, 2010

Invasive fungal infection (IFI) is a serious threat after allogeneic hematopoietic cell transplant (HCT). This multicenter, 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 was assayed twice weekly for 60 days, then at least weekly until day 100. Positive galactomannan 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 = .12), Aspergillus infections (9 vs 17; P = .09), and less frequent empiric antifungal therapy (24.1% vs 30.2%, P = .11) with voriconazole, FFS rates (75% vs 78%; P = .49) at 180 days were similar with fluconazole and voriconazole, respectively. Relapse-free and overall survival 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 overall survival did not differ in allogeneic HCT recipients given prophylactic fluconazole or voriconazole. This trial was registered at www.clinicaltrials.gov as NCT00075803.

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Published In

Blood

DOI

EISSN

1528-0020

Publication Date

December 9, 2010

Volume

116

Issue

24

Start / End Page

5111 / 5118

Location

United States

Related Subject Headings

  • Young Adult
  • Transplantation, Homologous
  • Survival Rate
  • Myeloablative Agonists
  • Mycoses
  • Middle Aged
  • Mannans
  • Immunology
  • Humans
  • Hematopoietic Stem Cell Transplantation
 

Citation

APA
Chicago
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MLA
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Wingard, J. R., Carter, S. L., Walsh, T. J., Kurtzberg, J., Small, T. N., Baden, L. R., … Blood and Marrow Transplant Clinical Trials Network, . (2010). Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation. Blood, 116(24), 5111–5118. https://doi.org/10.1182/blood-2010-02-268151
Wingard, John R., Shelly L. Carter, Thomas J. Walsh, Joanne Kurtzberg, Trudy N. Small, Lindsey R. Baden, Iris D. Gersten, et al. “Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation.Blood 116, no. 24 (December 9, 2010): 5111–18. https://doi.org/10.1182/blood-2010-02-268151.
Wingard JR, Carter SL, Walsh TJ, Kurtzberg J, Small TN, Baden LR, et al. Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation. Blood. 2010 Dec 9;116(24):5111–8.
Wingard, John R., et al. “Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation.Blood, vol. 116, no. 24, Dec. 2010, pp. 5111–18. Pubmed, doi:10.1182/blood-2010-02-268151.
Wingard JR, Carter SL, Walsh TJ, Kurtzberg J, Small TN, Baden LR, Gersten ID, Mendizabal AM, Leather HL, Confer DL, Maziarz RT, Stadtmauer EA, Bolaños-Meade J, Brown J, Dipersio JF, Boeckh M, Marr KA, Blood and Marrow Transplant Clinical Trials Network. Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation. Blood. 2010 Dec 9;116(24):5111–5118.

Published In

Blood

DOI

EISSN

1528-0020

Publication Date

December 9, 2010

Volume

116

Issue

24

Start / End Page

5111 / 5118

Location

United States

Related Subject Headings

  • Young Adult
  • Transplantation, Homologous
  • Survival Rate
  • Myeloablative Agonists
  • Mycoses
  • Middle Aged
  • Mannans
  • Immunology
  • Humans
  • Hematopoietic Stem Cell Transplantation