Fungal Infection Susceptibility

Conditions

• Cryptococcal Infection
• Cryptococcal Meningitis
• Cryptococcal Pneumonia
• Cryptococcosis
• Pulmonary Cryptococcosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Accepted

Study Details

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 Dates

Start date

Apr 1, 1993

Status verified

Jun 2026

Study Design

Enrollment

800 participants (estimated)

Arms

• Arm: Blood Relatives
  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.
• Arm: Healthy Volunteers
  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.
• Arm: Patient Population
  Previously healthy adult patients diagnosed with Cryptococcosis and have no predisposing conditions, such as HIV.

Primary Outcome Measure

Characterize the full spectrum of clinical disease of Cryptococcosis in previously healthy adults without known immune predisposition. [ Time Frame: 1-5 years ]

Central Contacts

• Peter R Williamson, M.D.
  (301) 443-8339
  [email protected]

Locations (1)

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