Trial Information

Surveillance of Invasive Fungal Infections in Bone Marrow/Stem Cell and Solid Organ Transplantation Recipients and Other Immunocompromised Patients: A Prospective Study

Background:

Invasive fungal infections have emerged as important causes of morbidity and mortality among
recipients of bone marrow, stem cell, and solid organ transplantation (SOT), as well as
patients receiving intensive chemotherapy for treatment of hematological malignancies,
patients with aplastic anemia, and patients with inherited immunodeficiencies.

This study has been formerly conducted through a surveillance network of BMT/SCT and SOT
centers through collaboration with the Centers for Disease Control for the surveillance of
invasive fungal infections in recipients of bone marrow, stem cell transplantation, and
solid organ transplantations.

The first three phases of this study will have been conducted over a six-year period at
approximately 23 collaborating transplant centers and completed enrollment of multi-center
cases of March 31, 2006.

The addition of a fourth phase allows the study of cases of invasive fungal infections to
continue by extending the protocol for four 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.

Objectives:

The objective of this study is to conduct multi-institutional surveillance for invasive
fungal infections in recipients of bone marrow, stem cell transplantation, and solid organ
transplantations, as well as in immunocompromised patients within the Clinical Center
patient population.

To maintain a multi-institute surveillance network to evaluate new approaches to the
prevention and diagnosis of invasive fungal infections through the analysis of immune
function, to include antigen detection, within the population of patients who develop
invasive fungal infections.

Eligibility:

Any patient within the NIH Clinical Center receiving a bone marrow transplantation,
peripheral stem cell transplantation or solid organ transplantation, or any patient with an
inherited immunodeficiency, aplastic anemia or oncologic diagnosis meeting EORTC/MSG
criteria for an invasive infection.

Design:

This is a prospective surveillance study of invasive fungal infections in the
immunocompromised host population.

An incident case will be defined as any transplant recipient, or an immunocompromised
patient (i.e., having inherited immunodeficiencies, aplastic anemia or general oncology)
with proven or probable invasive fungal infection meeting the criteria for IFI as described
by the MSG/EORTC guidelines.

Positive microbiological evidence will prompt acquisition of discarded serum and blood from
the Department of Laboratory Medicine for analysis of immune function, to include antigen
detection, to evaluate new approaches to the prevention and diagnosis of invasive fungal
infections.