Micafungin versus fluconazole for prophylaxis against invasive fungal infections during neutropenia in patients undergoing hematopoietic stem cell transplantation

Jo Anne H. Van Burik, Voravit Ratanatharathorn, Daniel E. Stepan, Carole B. Miller, Jeffrey H. Lipton, David H. Vesole, Nancy Bunin, Donna A. Wall, John W. Hiemenz, Yoichi Satoi, Jeanette M. Lee, Thomas J. Walsh

Research output: Contribution to journalArticlepeer-review

652 Scopus citations

Abstract

We hypothesized that chemoprophylaxis with the echinocandin micafungin would be an effective agent for antifungal prophylaxis during neutropenia in patients undergoing hematopoietic stem cell transplantation (HSCT). We therefore conducted a randomized, double-blind, multi-institutional, comparative phase III trial, involving 882 adult and pediatric patients, of 50 mg of micafungin (1 mg/kg for patients weighing <50 kg) and 400 mg of fluconazole (8 mg/kg for patients weighing <50 kg) administered once per day. Success was defined as the absence of suspected, proven, or probable invasive fungal infection (IFI) through the end of therapy and as the absence of proven or probable IFI through the end of the 4-week period after treatment. The overall efficacy of micafungin was superior to that of fluconazole as antifungal prophylaxis during the neutropenic phase after HSCT (80.0% in the micafungin arm vs. 73.5% in the fluconazole arm [difference, 6.5%]; 95% confidence interval, 0.9%-12%; P = .03). This randomized trial demonstrates the efficacy of an echinocandin for antifungal prophylaxis in neutropenic patients.

Original languageEnglish (US)
Pages (from-to)1407-1416
Number of pages10
JournalClinical Infectious Diseases
Volume39
Issue number10
DOIs
StatePublished - Nov 15 2004

Bibliographical note

Funding Information:
Financial support. Funding for this study was provided by Fujisawa Healthcare through individual grants to the participating sites. The work in this article was supported in part by the National Institute of Allergy and Infectious Disease Mycoses Study Group NO1-AI-65296 and by funds from Fujisawa Healthcare.

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