Detection and Characterization of Infections and Infection Susceptibility
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|ClinicalTrials.gov Identifier: NCT00404560|
Recruitment Status : Enrolling by invitation
First Posted : November 29, 2006
Last Update Posted : February 8, 2019
This screening study will examine the causes of immune disorders affecting white blood cells, which defend against infections and will try to develop better means of diagnosis and treatment of these immune disorders. This is a 2 visit screening study and patients determined to be of interest for additional study or treatment will be asked to provide consent for enrollment into an appropriate NIH follow up study. This study does not cover the cost of the first visit to NIH for travel or lodgings but does cover the subsequent visit if there is one. A financial assessment may determine if the patient is eligible for financial assistance. This study does not enroll children under the age of 2.
Patients known to have or suspected of having increased susceptibility to infections and their blood relatives may be eligible for this study, at the discretion of the principal investigator. Patients and family members may undergo the following procedures:
- Personal and family medical history.
- Physical examination and blood and urine tests.
- Studies of breathing function (pulmonary function testing)
- Dental examination.
- Eye examination.
- Genetic Testing
- Stored specimens for future analysis
- Microscopic examination of saliva, wound drainage or tissues removed for medical reasons for cell, hormone or DNA studies.
In addition, patients will be asked to obtain permission for investigators to obtain their medical records, previous test results, or radiographic studies prior to the first visit. Patients will be asked to undergo imaging studies, such as a chest X-ray, CT scan or MRI scan.
|Condition or disease|
|Immune Disorders Chronic Granulomatous Disease Genetic Immunological Deficiencies Hyperimmunoglobulin-E Recurrent Infection Syndrome Recurrent Infections Unknown Immune Deficiency GATA2 Deficiency (MonoMAC) Nontuberculous Mycobacterial Infections Hyper IgE (Job s) Syndrome Leukocyte Adhesion Deficiency Susceptibility to Disseminated Infections Primary Immune Deficiency Disease (PIDD)|
|Study Type :||Observational|
|Actual Enrollment :||1348 participants|
|Official Title:||Screening Protocol for Detection and Characterization of Infections and Infection Susceptibility|
|Study Start Date :||November 27, 2006|
- The primary endpoint of this study will be determination of a discretediagnosis of an infecting agent, an underlying susceptibility trait, or both. [ Time Frame: Within 2 visits ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404560
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven M Holland, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|