Evaluation and Follow-up of Patients With Cryptococcosis
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||November 27, 2013|
|Start Date ICMJE||March 1993|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|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.
Cryptococcosis is a fungus which causes infection in immunocompromised patients, such as those with the acquired immunodeficiency syndrome, but also in occasional persons who have been previously healthy. The reasons for infection of ostensibly normal persons remain unclear. Now that enumeration of lymphocyte subpopulations has become more common, a low number of DC4 cells have been found in some cryptococcosis patients. These patients fit the CDC definition of idiopathic CD4 Lymphocytopenia (ICL) in that they have CD4 levels below 300/microl, no laboratory evidence of HIV infection and no defined immunodeficiency or therapy associated with depressed CD4 levels. One of the first five cases of ICL reported in that issue of MMWR was presented with cryptococcal meningitis. According to Dr. Harold Jaffe at CDC, about one fourth of the ICL cases reported to CDC by December, 1992 have presented with cryptococcosis (personal communication.) However the incidence of ICL in cryptococcosis patients is unknown. Also, the long term outcome of patients with cryptococcosis and ICL patients is unclear. For example, it is not known if they are more difficult to cure than other previously normal patients, as would be the case had they been HIV seropositive.
In addition, novel discovery methods such as genome wide association studies (GWAS) of copy number variation (CNV) and single nuclear polymorphisms (SNP s) have been used to identify genes involved in patient diseases. We would thus like to supplement the methods previously used in this protocol with genetic comparisons, maintaining the original objectives of the study.
This protocol will bring to NIH patients with cryptococcosis who have no underlying disease, either with or without prior treatment of their mycosis. Those who have ICL will be compared with those not having ICL for response to treatment, prior and future opportunistic infections other than cryptococcosis, and future course of the lymphocyte subpopulations.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|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||400|
|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 and older|
|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||Not Provided|
|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||December 2012|
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