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Immune and Genetic Factors in Cryptococcosis for Previously Healthy Adults

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Study Aim

This study observes the immune and genetic factors in previously healthy adults to understand the full spectrum of Cryptococcosis disease.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Neuroinflammatory Diseases+9

+ Bacterial Infections and Mycoses

+ Central Nervous System Diseases

From 18 to 99 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 1993
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactPeter R Williamson, M.D.
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1993

Actual date on which the first participant was enrolled.

Cryptococcus is a fungus that can cause serious infections, often in people with weakened immune systems, such as those with AIDS or organ transplants. However, some people without known immune issues also get these infections. This study focuses on understanding why seemingly healthy adults, who do not appear to have immune problems, develop cryptococcosis. The aim is to uncover any genetic or immune factors that might make these individuals more susceptible. By learning more about these hidden factors, researchers hope to improve treatment options and outcomes for those affected. In this study, both patients with cryptococcosis and healthy volunteers will participate. Participants will provide samples like saliva, blood, and even eyebrow hair and nail clippings. For those with the infection, standard medical care will be given, and if needed, treatments like corticosteroids may be used to manage symptoms. Researchers will compare the samples from patients and healthy individuals to identify any genetic or immune differences. This study will help find the underlying reasons for susceptibility to cryptococcosis and could lead to new treatment methods in the future.

Official TitleCryptococcosis in Previously Healthy Adults
NCT00001352
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactPeter R Williamson, M.D.
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

800 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neuroinflammatory DiseasesBacterial Infections and MycosesCentral Nervous System DiseasesCentral Nervous System InfectionsCryptococcosisInfectionsMeningitisMycosesNervous System DiseasesMeningitis, CryptococcalMeningitis, FungalCentral Nervous System Fungal Infections

Criteria

9 inclusion criteria required to participate
Be over the age of 18 years old.
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.
Have a primary physician outside of the NIH.
Agree to undergo genetic testing that will include WES and high density SNP arrays as appropriate for possible WES linkage studies.
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9 exclusion criteria prevent from participating
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
1. HIV or viral hepatitis (B or C).
2. History of recurrent or severe infections.
3. History of intravenous drug use.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
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One Study Center