Fungal Infection Susceptibility

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Keywords

ClinConnect Summary

This clinical trial is studying a fungal infection called cryptococcosis, which can affect previously healthy individuals without a clear reason for their illness. The goal is to understand how this disease develops and progresses over time. People who are eligible to participate include adults over 18 years old who have tested positive for the fungus (either C. neoformans or C. gattii) and do not have conditions like HIV or certain cancers that could increase their risk for this infection. Family members of patients and healthy volunteers between 18 and 70 years old can also join the study.

Participants can choose to attend follow-up visits either in person at the NIH Clinical Center or through telehealth appointments, which allow them to connect with doctors remotely. During these visits, participants will have various health assessments, including physical exams and lab tests, to monitor their condition. The study may last up to 5 years, and participants will also agree to undergo some genetic testing. It’s important to note that pregnant individuals are not excluded from the study, but certain high-risk procedures would not be performed on them. Overall, this trial aims to gather valuable information that could help in understanding and treating cryptococcosis better.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• Patients:
• Patients must:
• 1. Have cryptococcosis as determined by information collected from their medical records, telephone interviews or from a referring physician:
• • histopathology showing cryptococci; or
• • culture of C. neoformans or C. gattii
• • a positive cryptococcal antigen in the serum and/or CSF, together with CSF cell count and chemistry consistent with cryptococcal meningitis.
• • 2. Be over the age of 18 years old.
• • 3. Have a primary physician outside of the NIH.
• • 4. Agree to undergo genetic testing that will include WES and high density SNP arrays as appropriate for possible WES linkage studies.
• • 5. Allow samples to be stored for future research.
• • 6. Pregnant patient willnot be excluded; However, research procedures greater than minimal risk including bone marrow biopsy and apheresis would not be performed on pregnant subjects. Otherwise, pregnant patients with cryptococcus would be treated as per standard of care, minimizing teratogenic potential of drugs and ionizing radiation whenever possible.
• Genetic Relatives of Patients:
• Genetic relatives must:
• • 1. Be a genetic relative of a patient enrolled in this study
• • 2. Be over the age of 18 years old
• • 3. Agree to undergo genetic testing that may include WES and high density SNP analysis
• • 4. Allow samples to be stored for future research
• Healthy Volunteers:
• Healthy volunteers must:
• • 1. Be between the ages of 18 and 70 years old
• • 2. Allow samples to be stored for future research
• EXCLUSION CRITERIA:
• • Patients
• Patients will be excluded for any of the following:
• 1. The presence of certain types of acquired abnormalities of immunity due to:
• • HIV
• • Cancer chemotherapeutic agent(s)
• • An underlying malignancy could be grounds for possible exclusion of a patient if in the opinion of the investigator, the underlying disease predisposed the patient to the infection
• • Monoclonal antibody therapy directed against a patient s immune system
• • 2. Any condition that in the medical opinion of the investigator may interfere with the evaluation of a co-existing abnormality of immunity that is exclude patients with Cushing s disease that have very high cortisol levels at the time of diagnosis of their cryptococcosis.
• Genetic Relatives of Patients:
• Genetic relatives will be excluded for the following:
• • Pregnancy
• • Any condition that in the medical opinion of the investigator may interfere with evaluation of an immune system abnormality that is the subject of study under this protocol.
• Healthy Volunteers:
• Healthy volunteers will be excluded for any of the following:
• • 1. History of HIV or viral hepatitis (B or C).
• • 2. History of recurrent or severe infections.
• • 3. History of intravenous drug use.
• • 4. History of engaging in high risk activities for exposure to HIV;
• • 5. Receiving chemotherapeutic agent(s), immunosuppressants or have underlying malignancy.
• • 6. Pregnancy.
• • 7. Have history of heart, lung, kidney disease, or bleeding disorders.
• • 8. Any condition that in the medical opinion of the investigator may interfere with evaluation of an immune system abnormality that is the subject of study under this protocol.

Trial Officials