Trial record 1 of 1 for:    NCT00001352
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Evaluation and Follow-up of Patients With Cryptococcosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001352
First received: November 3, 1999
Last updated: March 14, 2014
Last verified: December 2013

November 3, 1999
March 14, 2014
March 1993
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Complete list of historical versions of study NCT00001352 on ClinicalTrials.gov Archive Site
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Evaluation and Follow-up of Patients With Cryptococcosis
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.

Observational
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  • Cryptococcosis
  • Lymphopenia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
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  • INCLUSION CRITERIA:

    1. Positive culture of Cryptococcus neoformans from any body site;
    2. First degree relative (mother, father, sister, brother) of patients with positive Cryptococcus neoformans from anybody site.
    3. Age 18 years or older; and
    4. Ability to provide informed consent.

EXCLUSION CRITERIA (Apply to patients only):

  1. Known HIV positive serology or other condition predisposing to cryptococcosis, including but not limited to corticosteroid therapy equivalent to prednisone 20 mg per day or more or acidosis.
  2. Dementia impairing informed consent.

INCLUSION CRITERIA FOR CONTROLS:

  1. History of ICL without a history of cryptococcosis or
  2. Other conditions which may predispose to cryptococcosis, such as other opportunistic infections and autoimmune diseases.

EXCLUSION CRITERIA FOR CONTROLS:

  1. Iatrogenic immunodeficiency such as concomitant corticosteroid treatment (greater than an equivalent of 10 mg of prednisone daily for more than 2 weeks), other immunosuppressive medications, total body irradiation or others
  2. Dementia impairing informed consent.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

  1. Weight greater than 110 lbs
  2. Hemoglobin level greater than 11 g/dl
  3. Ages 18-70

EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

  1. History of hepatitis B or hepatitis C
  2. HIV positivity
  3. Any condition which in the opinion of the investigators may alter immune function
Both
18 Years and older
Yes
Contact: John E Bennett, M.D. (301) 402-0198 jbennett@niaid.nih.gov
United States
 
NCT00001352
930106, 93-I-0106
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: John E Bennett, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP