An observational study in Cryptococcal Infection, Cryptococcal Pneumonia and Pulmonary Cryptococcosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
The protocol will be carried out in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and the following United States Code of Federal Regulations (CFR) applicable to clinical studies: 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812.
NIH-funded investigators and study site staff who are responsible for the conduct, management, or oversight of NIH-funded studies have completed Human Subjects Protection and ICH GCP Training.
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. In addition, all changes to the consent form will be approved by the IRB; an IRB determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.
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Cryptococcus is a fungus that causes infections most commonly in immunocompromised patients, such as those with AIDS and solid organ transplant recipients, particularly renal transplant recipients (1-3). However, approximately one-third of cases fall outside these groups and, overall, 12.9 percent to 17.9 percent have no readily identifiable immune defect (4, 5). The genetic factors, which may predispose to cryptococcosis and the immune response in these patients, have not been extensively studied.
This protocol is designed to examine the immune deficits that predispose to cryptococcosis as well as the clinical and immune responses among previously healthy adults. The patients included will have an unknown predisposing condition and cryptococcosis. Patients will undergo various sampling procedures, including saliva, blood, eyebrow hair, CSF, and nail clipping collection. Throughout the study, patients will be provided with standard medical care and will be seen as often as necessary to manage their condition. Patients in whom microbiologic control of the infection has occurred but in whom inflammation is causing neurologic damage may be treated with corticosteroids or other immunosuppressive agents. Genetically related family members of patients will also be screened for clinical, in vitro, immune, and genetic correlates of immune abnormalities. Healthy adult volunteers, as a comparison group, will be enrolled as a source of blood samples, saliva samples, CSF samples, and eyebrow hair samples for research testing. Moreover, with respect to cryptococcosis, patients with isolated non-central nervous system (CNS) disease (e.g., pulmonary) may serve as a subset comparator to those with CNS involvement-a major tissue tropism for Cryptococcus.
Genetic and immunologic testing will be performed on all subjects (patients, relatives, and healthy volunteers) to evaluate for possible immunogenetic factors that lead to susceptibility to cryptococcosis. Among the aims of this protocol are to better understand the pathophysiology and genetic factors that lead to defects in host defense and to use modern and evolving methods in molecular and cellular biology to elucidate the pathogenesis of this particular susceptibility. A better understanding of the underlying pathophysiology of immune defects and genetic susceptibility to fungal infections could allow for the rational development of novel therapies for such diseases and to benefit future patients.
54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.
Browse Meningitis, Cryptococcal studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients
Patients must:
Have cryptococcosis as determined by information collected from their medical records, telephone interviews, or from a referring physician:
Blood Relatives of Patients
Blood relatives must:
Healthy Volunteers
Healthy volunteers must:
EXCLUSION CRITERIA:
Patients
Patients will be excluded for any of the following:
The presence of certain types of acquired abnormalities of immunity due to:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will be placed in a control group. Must be a blood relative of a patient enrolled in the study. Participant age must be 18 years or older. Relatives may be excluded if they have a condition that may interfere with evaluation of an immune system abnormality.
Will be placed in a control group. Participant age must be 18 years or older. Healthy volunteers will be excluded if they have HIV, viral hepatitis (B or C), history of recurrent or severe infections, history of intravenous drug use, history of engaging in high-risk activities for HIV exposure, receiving chemotherapeutic agents, immunosuppressants, have underlying malignancies, pregnancy, or a history of heart disease, lung disease, kidney disease, or bleeding disorders.
Previously healthy adult patients diagnosed with Cryptococcosis and have no predisposing conditions, such as HIV.
Characterize the full spectrum of clinical disease of Cryptococcosis in previously healthy adults without known immune predisposition.
Time frame: 1-5 years
Characterize the immunological and genetic mechanisms predisposing to disease acquisition.
Time frame: 1-5 years
Understand the inflammatory response and distinguish its consequences from those directly due to fungal growth.
Time frame: 1-5 years
Understand the natural history of disease progression or regression over time.
Time frame: 1-5 years
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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