Detection and Characterization of Infections and Infection Susceptibility
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00404560|
Recruitment Status : Enrolling by invitation
First Posted : November 29, 2006
Last Update Posted : October 7, 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|
|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|
healthy blood relatives
relatives not ill with a known or suspected infection susceptibility syndrome
patients who either have, or are suspected of having, an infection or infection susceptibility in order to further characterize such conditions
- determination of a discrete diagnosis of an infecting agent, an underlying susceptibility trait, or both. [ Time Frame: upon diagnosis or after the second visit ]patients determined to have a diagnosis or syndrome that requires further study at the NIH will be asked to provide consent for enrollment into an appropriate study for further diagnosis and/or treatment
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)|