Fungal Infection Susceptibility

Recruiting now

Conditions studied: Cryptococcal Infection, Cryptococcal Pneumonia, Pulmonary Cryptococcosis, Cryptococcal Meningitis, Cryptococcosis

In brief

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.

Key facts

Study ID

NCT00001352

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

800

Starts

1993-04-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Patients
• Patients will be excluded for any of the following:
• 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
• 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:
• HIV or viral hepatitis (B or C).
• History of recurrent or severe infections.
• History of intravenous drug use.
• History of engaging in high-risk activities for exposure to HIV.
• Receiving chemotherapeutic agent(s), immunosuppressants or have underlying malignancy.
• Pregnancy.
• Have history of heart, lung, kidney disease, or bleeding disorders.
• 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.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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