Evaluation and Follow-up of Patients With Cryptococcosis
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||October 21, 2014|
|Start Date ICMJE||March 1993|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001352 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation and Follow-up of Patients With Cryptococcosis|
|Official Title ICMJE||Genetic Susceptibility to Cryptococcal and Other Systemic Fungal Infections in Adults|
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||600|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
EXCLUSION CRITERIA (Apply to patients only):
INCLUSION CRITERIA FOR CONTROLS:
EXCLUSION CRITERIA FOR CONTROLS:
INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001352|
|Other Study ID Numbers ICMJE||930106, 93-I-0106|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP