| NCT ID | NCT00001352 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Cryptococcal Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 1993-04-01 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 1993-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
* 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 marrow biopsy and apheresis would not be performed on pregnant subjects. Otherwise, pregnant patients with cryptococcus would be treated with as per standard of care, minimizing teratogenic potential of drugs and ionizing radiation whenever possible. Blood Relatives of Patients Blood relatives must: 1. Be a genetic relative of a patient enrolled in this study 2. Be over the age of 18 years old 3. Agree to undergo genetic testing that may include WES and high density SNP analysis 4. Allow samples to be stored for future research Healthy Volunteers Healthy volunteers must: 1. Be between the ages of 18 and 70 years old 2. Allow samples to be stored for future research EXCLUSION CRITERIA: Patients Patients will be excluded for any of the following: 1. 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 2. 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: 1. HIV or viral hepatitis (B or C). 2. History of recurrent or severe infections. 3. History of intravenous drug use. 4. History of engaging in high-risk activities for exposure to HIV. 5. Receiving chemotherapeutic agent(s), immunosuppressants or have underlying malignancy. 6. Pregnancy. 7. Have history of heart, lung, kidney disease, or bleeding disorders. 8. 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.
Contact & Investigator
Peter R Williamson, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT00001352 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Cryptococcal Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00001352 currently recruiting?
Yes, NCT00001352 is actively recruiting participants. Contact the research team at williamsonpr@mail.nih.gov for enrollment information.
Where is the NCT00001352 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00001352 clinical trial?
NCT00001352 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Peter R Williamson, M.D. at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 800 participants.