Antifungal prophylaxis in solid-organ transplant recipients: considerations for clinical trial design.
BACKGROUND
There are several key issues regarding clinical trial design for antifungal prophylaxis in organ transplant recipients.


METHODS
The existing and emerging data on the epidemiology and risk factors for invasive mycoses in organ transplant recipients formed the basis for discerning the subgroups that may be targeted for prophylaxis, the unique end points to be considered, and the attributes of currently available drugs that may be suitable candidates for antifungal prophylaxis.


RESULTS
Epidemiological characteristics of invasive mycoses in organ transplant recipients have evolved sufficiently to warrant thoughtful reconsideration of the subsets of patients and the fungal pathogens to be targeted for antifungal prophylactic trials in the current era. Safety and tolerability of antifungal agents and outcome stratified by severity of illness are important end points given the potential for drug interactions with immunosuppressive agents and the fact that a beneficial effect of prophylaxis on outcome has been difficult to document in organ transplant recipients.


CONCLUSIONS
Clinical trial design for antifungal prophylaxis must carefully consider the unique issues pertaining to the selection of patients most likely to benefit, as well as the tolerability and drug interactions of antifungal agents in organ transplant recipients.
Singh
Nina
N
Veterans Affairs Medical Center and University of Pittsburgh, Thomas E. Starzl Transplantation Institute, Pittsburgh, PA 15240, USA. nis5+@pitt.edu
D000935:Antifungal Agents / Q000627:therapeutic use*; D001228:Aspergillosis / Q000453:epidemiology / Q000517:prevention & control*; D002986:Clinical Trials as Topic; D005544:Forecasting; D006801:Humans; D016867:Immunocompromised Host / Q000276:immunology; D011315:Preventive Medicine; D012107:Research Design; D012307:Risk Factors; D014180:Transplantation; D019737:Transplants / Q000009:adverse effects*
D000935:Antifungal Agents