| Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation. | |
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MedLine Citation:
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PMID: 20826719 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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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:
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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:
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Title: Blood Volume: 116 ISSN: 1528-0020 ISO Abbreviation: Blood Publication Date: 2010 Dec |
Date Detail:
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Created Date: 2010-12-14 Completed Date: 2011-01-06 Revised Date: 2013-03-21 |
Medline Journal Info:
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Nlm Unique ID: 7603509 Medline TA: Blood Country: United States |
Other Details:
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Languages: eng Pagination: 5111-8 Citation Subset: AIM; IM |
Affiliation:
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University of Florida, Gainesville, FL, USA. wingajr@medicine.ufl.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00075803 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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U01 HL069274/HL/NHLBI NIH HHS; U01-8L069294//PHS HHS |
| Chemical | |
Reg. No./Substance:
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0/Antifungal Agents; 0/Mannans; 0/Myeloablative Agonists; 11078-30-1/galactomannan; 86386-73-4/Fluconazole |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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