Fungal Infection Susceptibility
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
| Condition(s) | Cryptococcal Infection, Cryptococcal Pneumonia, Pulmonary Cryptococcosis, Cryptococcal Meningitis, Cryptococcosis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 b |
| Who can participate | * INCLUSION CRITERIA: Patients Patients must: 1. Have cryptococcosis as determined by information collected from their medical records, telephone interviews, or from a referring physician: * 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. 2. Be over the age of 18 years old. 3. Have a primary physician outside of the NIH. 4. Agree to undergo genetic testing that will include WES and high density SNP arrays as appropriate for possible WES linkage studies. 5. Allow samples to be stored for future research. 6. Pregnant patients will not be excluded. However, research procedures greater than minimal risk including bone marr |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Locations | Bethesda, Maryland, United States |
| Start date | 1993-04-01 |
| NCT ID | NCT00001352 |
| Official listing | https://clinicaltrials.gov/study/NCT00001352 |