Actively Recruiting

Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT00001352

Fungal Infection Susceptibility

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-28

800

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fungal Infection Susceptibility

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have cryptococcosis confirmed by histopathology, culture, or positive cryptococcal antigen with supporting CSF results
  • Patients must be over 18 years old
  • Patients must have a primary physician outside of the NIH
  • Patients must agree to genetic testing including whole exome sequencing and SNP arrays
  • Patients must allow samples to be stored for future research
  • Pregnant patients are allowed but some research procedures will be avoided
  • Blood relatives must be genetic relatives of enrolled patients
  • Blood relatives must be over 18 years old
  • Blood relatives must agree to genetic testing and sample storage
  • Healthy volunteers must be between 18 and 70 years old
  • Healthy volunteers must allow samples to be stored for future research
Not Eligible

You will not qualify if you...

  • Patients with HIV infection
  • Patients receiving cancer chemotherapy
  • Patients with underlying malignancies if deemed to predispose to infection
  • Patients treated with monoclonal antibody therapy affecting the immune system
  • Patients with conditions interfering with immune evaluation, such as Cushing's disease with high cortisol
  • Genetic relatives with conditions interfering with immune evaluation
  • Healthy volunteers with HIV or viral hepatitis B or C
  • Healthy volunteers with history of recurrent or severe infections
  • Healthy volunteers with history of intravenous drug use or high-risk behaviors for HIV
  • Healthy volunteers receiving chemotherapy, immunosuppressants, or with malignancy
  • Healthy volunteers who are pregnant
  • Healthy volunteers with history of heart, lung, kidney disease, or bleeding disorders
  • Healthy volunteers with conditions interfering with immune evaluation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

P

Peter R Williamson, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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