The FUNGI study is looking for the following participants:
- People who have developed invasive fungal infections (IFIs), such as aspergillosis, without any prior immune system problems
- People with autoimmune endocrinopathy-candidiasis-ectodermal dystrophy (APECED) syndrome
The study is investigating why some people are susceptible to IFIs even without underlying immune deficiency. It will explore genetic and immune system factors that may contribute to the condition.
IFIs are infections caused by fungi, such Aspergillus, and spread in the body through the blood stream or the respiratory tract. Although most infections are opportunistic (meaning they affect patients with compromised immune systems, such as those undergoing cancer chemotherapy), some people experience IFIs without a known immune deficiency.
APECED is a rare autoimmune disease caused by a faulty gene. This condition affects mainly the endocrine glands but may also affect other organs. Symptoms start in childhood and may include hormonal problems and frequent infections of the mouth and the skin by the fungus Candida.
The FUNGI natural history study may help researchers at the National Institutes of Health (NIH) in Bethesda, Maryland, develop safe and more effective treatment options for patients in the future. If a study participant appears to have a genetic defect in his or her immune system, genetically related family members will also be offered participation. In addition, the study seeks healthy volunteers (those without the condition) to participate in testing.
Where is the study taking place?
The study is being conducted at the NIH Clinical Center in Bethesda, Maryland. The NIH campus is accessible by car and public transportation.
What does the study involve?
Participants will visit the NIH Clinical Center for the initial appointment and then approximately every six months. If unable to travel, participants may be able to participate by sending records and samples to NIH. Medical evaluations and procedures will vary based on a patient's disease course and may include a history/physical examination and blood, saliva, and possible tissue sampling for genetic and immunological testing. Optimal antifungal therapy may be offered for eligible patients.
How much does it cost?
There is no charge to participate in this research study. All study-related medical care, including clinic visits and procedures, are provided free of charge.
Will I receive payment?
Certain procedures, such as blood draws and tissue sampling, may be compensated. Transportation and other expenses may be covered.
Can I participate?
You may be eligible to participate if you or your child have active, persistent, or unusual mucocutaneous infections or IFIs with or without a primary or acquired immune deficiency state, particularly the following:
- Invasive aspergillosis or other invasive fungal infections without an underlying immune condition that explains the susceptibility to infection
- APECED syndrome
To learn more about this study (trial ID NCT01386437), visit ClinicalTrials.gov.