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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
  Purpose

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.


Condition
Cryptococcosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Genetic Susceptibility to Cryptococcal and Other Systemic Fungal Infections in Adults

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: March 1993
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001352

Contacts
Contact: John E Bennett, M.D. (301) 402-0198 jbennett@niaid.nih.gov

Locations
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    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: John E Bennett, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00001352     History of Changes
Other Study ID Numbers: 930106, 93-I-0106
Study First Received: November 3, 1999
Last Updated: October 21, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cryptococcus Neoformans
Cryptococcosis
CD4

Additional relevant MeSH terms:
Cryptococcosis
Mycoses

ClinicalTrials.gov processed this record on November 24, 2014