This study will collect data on the incidence (rate of occurrence) of fungal infections in recipients of bone marrow, stem cell or organ transplants. The data will provide information needed to develop strategies for prevention and early treatment of fungal infections in these patients.
Any patient receiving bone marrow transplantation, peripheral stem cell transplantation or solid organ transplantation is eligible for this study.
The survey will be conducted over a 3-year period at about 20 collaborating transplant centers. Through the annual accrual of more than 9,000 patients, it is estimated that at least 5 to 8 percent per year will have documented or suspected invasive fungal infections.
The study will be conducted in three phases as follows:
- Phase 1 - A 6-month "start-up" phase during which sites will initiate screening and begin collecting data on incident cases of invasive fungal infections.
- Phase 2 - A 2-year phase in which all sites will conduct surveillance and collect data and specimens in a standardized fashion.
- Phase 3 - A 6-month "wrap-up" phase during which active surveillance for invasive fungal infections will be conducted only among patients who were transplanted before the beginning of this phase.
Patient care will be provided through the patient's primary protocol and standard of care.
| Estimated Enrollment: |
250 |
| Study Start Date: |
April 2001 |
| Estimated Study Completion Date: |
January 2006 |
The objective of this study is to conduct muti-institutional surveillance for invasive fungal infections in recipients of bone marrow, stem cell transplantation, and solid organ transplantations, as well as in immunocompromised patients (i.e., inherited immunodeficiencies, aplastic anemia and general oncology who meet the EORTC/MSG Host criteria for invasive fungal infections) within the Clinical Center patient population. The first three phases of this study will have been conducted over a six-year period at approximately 23 collaborating transplant centers and will complete enrollment of multi-center cases by March 31, 2006. The addition of a forth phase will allow the study of cases of invasive fungal infections to continue by extending the protocol for two years at the NIH Clinical Center. It is estimated that at least 5-8% of immunocompromised patients will be accrued annually with documented or suspected invasive fungal infections. This will provide the necessary epidemiologic information and analysis of immune function and detection of surrogate microbial markers to develop strategies for prevention and early intervention for invasive fungal infections in this population.
Purpose
