Journal Article

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 and Thomas J. Walsh

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 39, issue 10, pages 1407-1416
Published in print November 2004 | ISSN: 1058-4838
Published online November 2004 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/422312
Micafungin versus Fluconazole for Prophylaxis against Invasive Fungal Infections during Neutropenia in Patients Undergoing Hematopoietic Stem Cell Transplantation

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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.

Journal Article.  4542 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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