Issues in the design of the fluconazole prophylaxis trials in patients undergoing hematopoietic stem cell transplantation.

Abstract

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.

• Authors: Kieren A Marr
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 39 Suppl 4 Pg. S170-5 (Oct 15 2004) ISSN: 1537-6591 [Electronic] United States
• PMID: 15546113 (Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antifungal Agents
• Fluconazole

Topics

• Antifungal Agents (therapeutic use)
• Fluconazole (therapeutic use)
• Hematopoietic Stem Cell Transplantation (adverse effects)
• Humans
• Mycoses (etiology, prevention & control)
• Preventive Medicine
• Research Design