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Immediate versus deferred empirical antifungal (IDEA) therapy in high-risk patients with febrile neutropenia: a randomized, double-blind, placebo-controlled, multicenter study.
MedLine Citation:
PMID:  23271674     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Empirical antifungal therapy is widely used in high-risk neutropenic hematology patients with fever persisting for more than 4 days. This clinical trial assessed whether immediate empirical therapy with voriconazole could lower the rates of invasive fungal infections (IFIs) compared with this approach. In a double-blind, placebo-controlled, multicenter study, patients with acute leukemia undergoing chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT) recipients were randomized to broad-spectrum antibacterial therapy plus voriconazole (immediate) or placebo (deferred) after the onset of neutropenic fever. If fever persisted for 96 h, patients were switched to open-label intravenous voriconazole; oral treatment was permitted after 96 h. The primary endpoint was the rate of proven/probable IFIs between Days 2 and 28 after fever onset in the modified intent-to-treat (mITT) complete-case population. One hundred and forty-seven patients were randomized to immediate (n = 81) or deferred (n = 66) voriconazole. In the mITT population, six patients in the immediate group and nine in the deferred group developed proven/probable IFI between Days 2 and 28 (p = 0.258). The safety profiles were similar in both groups. While immediate empirical therapy with voriconazole appears to be safe in febrile neutropenic high-risk patients, it was not associated with a significant reduction in IFIs compared with therapy deferred for 96 h after fever onset.
Authors:
G Maschmeyer; W J Heinz; B Hertenstein; H-A Horst; C Requadt; T Wagner; O A Cornely; J Löffler; M Ruhnke;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-28
Journal Detail:
Title:  European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology     Volume:  -     ISSN:  1435-4373     ISO Abbreviation:  Eur. J. Clin. Microbiol. Infect. Dis.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8804297     Medline TA:  Eur J Clin Microbiol Infect Dis     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Klinikum Ernst von Bergmann, Charlottenstrasse 72, 14467, Potsdam, Germany, gmaschmeyer@klinikumevb.de.
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