Search / Trial NCT00001352

Cryptococcosis in Previously Healthy Adults

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Trial Information

Current as of March 02, 2024

Recruiting

Keywords

Cryptococcus Natural History

Description

Cryptococcus is a fungus that causes infections most commonly in immunocompromised patients, such as those with AIDS and solid organ transplant recipients, particularly renal transplant recipients (1-3). However, approximately one-third of cases fall outside these groups and, overall, 12.9% to 17.9% have no readily identifiable immune defect (4, 5). The genetic factors, which may predispose to cryptococcosis and the immune response in these patients, have not been extensively studied. This protocol is designed to examine the immune deficits that predispose to cryptococcosis as well as the ...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • Patients:
  • Patients must:
  • 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.
  • Be over the age of 18 years old.
  • Have a primary physician outside of the NIH.
  • Agree to undergo genetic testing that will include WES and high density SNP arrays as appropriate for possible WES linkage studies.
  • Allow samples to be stored for future research.
  • Pregnant patient willnot 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 as per standard of care, minimizing teratogenic potential of drugs and ionizing radiation whenever possible.
  • Genetic Relatives of Patients:
  • Genetic relatives must:
  • Be a genetic relative of a patient enrolled in this study
  • Be over the age of 18 years old
  • Agree to undergo genetic testing that may include WES and high density SNP analysis
  • Allow samples to be stored for future research
  • Healthy Volunteers:
  • Healthy volunteers must:
  • Be between the ages of 18 and 70 years old
  • Allow samples to be stored for future research
  • EXCLUSION CRITERIA:
  • 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 medical opinion of the investigator may interfere with the evaluation of a co-existing abnormality of immunity that is 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:
  • Pregnancy
  • Any condition that in the medical 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:
  • History of 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 medical opinion of the investigator may interfere with evaluation of an immune system abnormality that is the subject of study under this protocol.

Attachments

readout_NCT00001352_2024-03-02.pdf

4.5 MB

NCT00001352_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

1-2 years

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0