Observational Study on Fungal Infection Susceptibility (Cryptococcosis)

This observational study is looking into why some healthy adults get cryptococcosis, a fungal infection, even without known immune problems. Researchers want to understand the full range of how this infection affects people and what might make them more likely to get it. You could join if you are an adult (18-99 years old) who has cryptococcosis, confirmed by tests like tissue samples, cultures, or a positive antigen test. The study aims to characterize the clinical disease over 1 to 5 years. There are no specific interventions or drugs being tested in this study; it's about observing and understanding the condition. The study is currently unclear on its status and plans to enroll 800 participants.

Study design
This is an observational study, meaning researchers will watch and learn from participants without giving them specific treatments. It plans to include 800 participants.
What's involved
You would undergo various sample collections, including saliva, blood, eyebrow hair, spinal fluid (CSF), and nail clippings. You will receive standard medical care for your condition.
Compensation
Not stated in the trial record.
Follow-up
The study aims to characterize the clinical disease of cryptococcosis over 1 to 5 years.

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NCT00001352

Fungal Infection Susceptibility

Recruiting
Not specifiedAges 18–99Observational
National Institute of Allergy and Infectious Diseases (NIAID)
~800 participants
Updated 2026-07-08 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterize the full spectrum of clinical disease of Cryptococcosis in previously healthy adults without known immune predisposition.
Measured over 1-5 years
Cryptococcal Infection
Cryptococcal Pneumonia
Pulmonary Cryptococcosis
Cryptococcal Meningitis
Cryptococcosis
1 sites across 1 states
Maryland1
  • Peter R Williamson, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

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Eligibility criteria

Inclusion

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 patients will not 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 with as per standard of care, minimizing teratogenic potential of drugs and ionizing radiation whenever possible.

Exclusion

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 opinion of the investigator may interfere with the evaluation of a co-existing abnormality of immunity that is the subject of study under this protocol. For example, we may exclude patients with Cushing s disease that have very high cortisol levels at the time of diagnosis of their cryptococcosis.
Any condition that in the opinion of the investigator may interfere with evaluation of an immune system abnormality that is the subject of study under this protocol.
  • Characterize the full spectrum of clinical disease of Cryptococcosis in previously healthy adults without known immune predisposition.1-5 years