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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 September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00001352
First received: November 3, 1999
Last updated: October 21, 2014
Last verified: September 2014

November 3, 1999
October 21, 2014
March 1993
Not Provided
  • 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 ]
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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.

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.

Observational
Time Perspective: Prospective
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Cryptococcosis
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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
600
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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 to 65 Years
Yes
Contact: John E Bennett, M.D. (301) 402-0198 jbennett@niaid.nih.gov
United States
 
NCT00001352
930106, 93-I-0106
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: John E Bennett, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
September 2014

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