Document Detail


Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation.
MedLine Citation:
PMID:  20826719     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
John R Wingard; Shelly L Carter; Thomas J Walsh; Joanne Kurtzberg; Trudy N Small; Lindsey R Baden; Iris D Gersten; Adam M Mendizabal; Helen L Leather; Dennis L Confer; Richard T Maziarz; Edward A Stadtmauer; Javier Bolaños-Meade; Janice Brown; John F Dipersio; Michael Boeckh; Kieren A Marr;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2010-09-08
Journal Detail:
Title:  Blood     Volume:  116     ISSN:  1528-0020     ISO Abbreviation:  Blood     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-12-14     Completed Date:  2011-01-06     Revised Date:  2014-04-29    
Medline Journal Info:
Nlm Unique ID:  7603509     Medline TA:  Blood     Country:  United States    
Other Details:
Languages:  eng     Pagination:  5111-8     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00075803
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Antifungal Agents
Aspergillosis / drug therapy,  prevention & control
Child
Child, Preschool
Disease-Free Survival
Double-Blind Method
Drug Monitoring
Fluconazole / administration & dosage*,  adverse effects
Hematologic Neoplasms / mortality,  therapy
Hematopoietic Stem Cell Transplantation / adverse effects*,  mortality
Humans
Mannans / blood
Middle Aged
Mycoses / drug therapy,  prevention & control*
Myeloablative Agonists / therapeutic use
Survival Rate
Transplantation, Homologous
Young Adult
Grant Support
ID/Acronym/Agency:
U01 HL069274/HL/NHLBI NIH HHS; U01-8L069294//PHS HHS; U10 HL069330/HL/NHLBI NIH HHS; U10 HL069348/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Antifungal Agents; 0/Mannans; 0/Myeloablative Agonists; 11078-30-1/galactomannan; 8VZV102JFY/Fluconazole
Comments/Corrections

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