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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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.
Be over the age of 18 years old.
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
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.
Cohort
Prospective
Not listed
Characterize the full spectrum of clinical disease of Cryptococcosis in previously healthy adults without known immune predisposition.
Characterize the immunological and genetic mechanisms predisposing to disease acquisition.
Understand the inflammatory response and distinguish its consequences from those directly due to fungal growth.
Understand the natural history of disease progression or regression over time.
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