Why do healthy people get this fungal infection? new study aims to find out
NCT ID NCT00001352
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 11 times
Summary
This study looks at 800 healthy adults who have cryptococcosis, a fungal infection that usually only harms people with weak immune systems. Researchers want to learn why these otherwise healthy people get sick, how their immune system responds, and how the disease progresses over time. No new treatments are being tested; the goal is to gather knowledge.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could reveal why some healthy people get cryptococcosis and point to better ways to predict or treat it.
- What could go wrong
- This is an observational study, not a treatment trial. It may not lead to any new therapies, and results may take years to apply.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 1993
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Study subjects will consist of previously healthy adults without known prior conditions who have cryptococcosis, blood relatives of these patients, and healthy adult volunteers. Potential Cryptococcus patients must be 18 or older with evidence of positive Cryptococcus infection results as shown through their medical records, telephone interviews or referring physician. This includes a positive Cryptococcus culture (neoformans or gattii), a positive cryptococcal antigen from serum or CSF with CSF cell count and chemistry consistent with Cryptococcus infection, or histopathology showing cryptococci. Blood relatives and healthy volunteers must be 18 years or older.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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 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. Blood Relatives of Patients Blood 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 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. Genetic Relatives of Patients Genetic relatives will be excluded for the following: -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. Healthy Volunteers Healthy volunteers will be excluded for any of the following: 1. 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 opinion of the investigator may interfere with evaluation of an immune system abnormality that is the subject of study under this protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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