Journal Article

Issues in the Design of the Fluconazole Prophylaxis Trials in Patients Undergoing Hematopoietic Stem Cell Transplantation

Kieren A. Marr

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 39, issue Supplement_4, pages S170-S175
Published in print October 2004 | ISSN: 1058-4838
Published online October 2004 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/421952
Issues in the Design of the Fluconazole Prophylaxis Trials in Patients Undergoing Hematopoietic Stem Cell Transplantation

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Today, invasive candidal infections are much less of a problem in patients undergoing hematopoietic stem cell transplantation (HSCT) than they were in the 1980s, principally because of widespread application of effective antifungal prophylaxis strategies. Two randomized, placebo-controlled studies performed in the early 1990s were instrumental in demonstrating the protective effects of fluconazole. Although both studies showed that candidiasis is prevented by fluconazole prophylaxis, controversies regarding optimal administration guidelines and the impact on survival after HSCT have persisted over the last decade. Details of how these trials were done, including the patients enrolled and end points evaluated, explain many of the different findings and controversies. An understanding of design issues can help explain current controversies and can assist in development of future prophylaxis studies.

Journal Article.  3450 words.  Illustrated.

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

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