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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001355 |
Purpose
This study will: 1) determine the biochemical and genetic causes of inherited immune diseases affecting phagocytes (white blood cells that defend against bacterial and fungal infections); and 2) try to develop better ways to diagnose and treat patients with these diseases, and to prevent, diagnose and treat their infections.
Patients with chronic granulomatous disease (CGD), hyper immunoglobulin-E recurrent infection syndrome (HIE or Job's syndrome), chronic and cyclic neutropenia, Chediak-Higashi syndrome (CHS), leukocyte adhesion deficiency (LAD), and disseminated mycobacterial infections, and their family members, may be eligible for this study. Normal volunteers between the 18 and 70 years of age will also be enrolled.
All participants will donate 1 to 3 ounces (2 to 6 tablespoons) of blood at a time, but no more than 1 pint (32 tablespoons) for adults and one-half teaspoon per pound of body weight for children over a 6-week period. They will also have DNA studies to try to identify genetic factors related to inherited immune disorders. In addition,
| Condition |
|---|
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Immunologic Deficiency Syndrome Infection |
| Study Type: | Observational |
| Official Title: | Detection and Characterization of Host Defense Defects |
| Estimated Enrollment: | 1200 |
| Study Start Date: | April 1993 |
| Estimated Primary Completion Date: | February 1998 (Final data collection date for primary outcome measure) |
This protocol is designed to evaluate selected patients with documented recurrent or unusual infections and their family members for clinical and in vitro correlates of immune abnormalities. It will also allow long term follow up of patients with host defense defects and permit us to periodically obtain blood, urine, saliva, or wound drainage from such patients or their family members for medically indicated purposes and research studies related to understanding the genetic and biochemical bases of these diseases. This protocol may help provide patients and materials for the development of therapies for these diseases.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients known to have or suspected of having an immune defect significantly or primarily involving the phagocytes will be eligible for enrollment, as well as their blood relatives. Such syndromes include but are not limited to chronic granulomatous disease (CGD), Hyper immunoglobulin-E recurrent infection syndrome (HIE or Job's syndrome), chronic and cyclic neutropenia, Chediak-Higashi syndrome (CHS), leucocyte adhesion deficiency (LAD), and disseminated mycobacterial infections. There will be no limit as age, sex, race or disability. Normal volunteers will be healthy adults between the age of 18 and 70 years and of either sex.
EXCLUSION CRITERIA:
The presence of an acquired abnormality which leads to immune defects, such as HIV, cytotoxic chemotherapy or malignancy could be grounds for possible exclusion if, in the opinion of the investigator, the presence of such disease process interfered with evaluation.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: Cathleen Frein, R.N. | (301) 402-1006 | freinc@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 930119, 93-I-0119 |
| Study First Received: | November 3, 1999 |
| Last Updated: | August 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00001355 History of Changes |
| Health Authority: | United States: Federal Government |
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Immunodeficiency Infections Phagocytes Cytokines Genetics |
|
Communicable Diseases Pathologic Processes Disease Immune System Diseases |
Syndrome Infection Immunologic Deficiency Syndromes |