Evaluation and Follow-up of Patients With Cryptococcosis
This 5-year study will follow the course of disease in previously healthy patients with cryptococcosis who developed the disease for no identifiable reason.
Individuals with a positive culture of Cryptococcus neoformans 18 years of age and older without HIV infection or other condition predisposing to cryptococcosis (such as high-dose corticosteroid therapy, sarcoidosis, or a blood cancer) may be eligible for this study. Candidates who test positive for HIV infection may not participate.
Participants will have a physical examination, medical history, routine blood tests and assessment of disease activity upon entering the study. Patients who may have active cryptococcosis will also have a lumbar puncture (spinal tap) and additional blood tests. Following the initial evaluation, patients receiving treatment for cryptococcosis will come to the NIH Clinical Center as needed to manage their disease, typically no less than every 3 months. Other patients will be seen every 6 to 12 months. The visits will include a medical history, physical examination, and blood and urine tests.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Genetic Susceptibility to Cryptococcal and Other Systemic Fungal Infections in Adults|
- Fungal Clearance [ Time Frame: 0, 2 weeks, 1m, 3, 6, and 12 months following the end of amphotericin B induction therapy ] [ Designated as safety issue: No ]
- Neurologic sequalae [ Time Frame: 0, 2 weeks, 1m, 3, 6, and 12 months following the end of amphotericin B induction therapy ] [ Designated as safety issue: No ]
|Study Start Date:||March 1993|
Cryptococcus is a fungus which causes infections in immunocompromised patients, such as those with AIDS, but occasionally, in persons who have no known immune defect. The genetic factors which may predispose to cryptococcosis and other fungal infections and the immune response in these patients have not been extensively studied.
This protocol is designed as a natural history study to examine primary immune deficiencies and other conditions associated with fungal infections. The patients included will have a known primary immune deficiency or unknown predisposing condition and have cryptococcosis, or other types of fungal infections. Patients will undergo blood, saliva, and tissue sampling. Throughout the study, patients will be provided with standard medical care and will be seen as often as necessary to manage their condition. Genetically related family members of patients will also be screened for clinical, in vitro and genetic correlates of immune abnormalities. Healthy volunteers and immunocompromised subjects without a history of fungal infections will be enrolled as a source of control blood and saliva samples for research testing.
Genetic testing will be performed on all subjects (patients, relatives, and controls) to evaluate for possible genetic factors that lead to susceptibility to fungal infections. Among the aims of this protocol are to better understand the pathophysiology and genetic factors that lead to defects in host defense and to use modern and evolving methods in molecular and cellular biology to elucidate the pathogenesis of this particular susceptibility. A better understanding of the underlying pathophysiology of immune defects and genetic susceptibility to fungal infections could allow for the rational development of novel therapies for such diseases and to benefit future patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001352
|Contact: John E Bennett, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||John E Bennett, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|