Detection and Characterization of Infections and Infection Susceptibility
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|ClinicalTrials.gov Identifier: NCT00404560|
Recruitment Status : Recruiting
First Posted : November 29, 2006
Last Update Posted : May 26, 2023
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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|
|Estimated Enrollment :||2000 participants|
|Official Title:||Screening Protocol for Detection and Characterization of Infections and Infection Susceptibility|
|Actual Study Start Date :||January 2, 2007|
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
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, Learn About Clinical Studies.
|Ages Eligible for Study:||1 Month and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- INCLUSION CRITERIA:
- Patients known to have, or suspected of having an infection susceptibility and their healthy blood relatives will be eligible for enrollment.
- Participants must be over 1 month of age. There will be no limit as to sex, race or disability.
- Patients must have a primary physician outside of the NIH and may be required to submit a letter from their physician that documents their relevant health history.
- The participant or the participant's guardian will be willing and capable of providing informed consent after initial counseling by clinical staff. Separate consent forms for all interventional procedures will be obtained after explanation of the specific procedure.
- Patients and relatives must agree to have blood and tissue stored for future studies of the immune system and/or other medical conditions.
- Patients and relatives may be concurrently enrolled on other protocols as long as the Principal Investigator is informed.
- The patient must be enrolled on this protocol to have relatives enrolled.
The patient and patient relative cohorts will include the following special populations:
- Children: Children are included in this study because immune defects may present in early childhood, and early diagnosis or characterization may benefit subjects. Children who do not meet the age and weight criteria for care at the Clinical Center, may have sample collection only.
- Decisionally impaired adults: Patients and patient relatives will be able to provide informed consent for themselves or, if they lack the capacity to provide informed consent, the study team will obtain consent from the legally authorized representative. Patients with underlying immune disorders, autoimmune phenomena or severe infections may sometimes present with delirium, encephalopathy, or coma and are therefore unable to provide informed consent. Excluding patients who are unable to provide consent could adversely impact patient access to medical therapy at the NIH as well as adversely impact research recruitment. Excluding patients unable to provide consent would also essentially prohibit us from evaluating patients at higher risk for adverse outcomes and therefore skew our understanding of disease. Similarly, enrolled patient subjects who lose the ability to provide ongoing consent during study participation may continue in the study. The risks and benefits of participation for subjects unable to consent should be identical to those described for less vulnerable patients.
- A well understood acquired abnormality which leads to infection susceptibility, such as HIV, cytotoxic chemotherapy, or active malignancy may be adequate explanation for the infection diathesis. These may be grounds for exclusion if, in the opinion of the investigators, the presence of such disease process interferes significantly with evaluation (applicable to patients and their blood relatives).
- Severe or uncommon infections or syndromes often require highly specialized teams and institutions. Some referred cases will not be able to be handled appropriately at the NIH and may be deemed ineligible for admission, as determined by the Principal Investigator.
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
|Contact: Dawn Shaw, R.N.||(301) email@example.com|
|Contact: Steven M Holland, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 email@example.com|
|Principal Investigator:||Steven M Holland, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
|First Posted:||November 29, 2006 Key Record Dates|
|Last Update Posted:||May 26, 2023|
|Last Verified:||May 22, 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||.We will share human data generated in this study for future research as follows:@@@@@@ (Summation)Identified data in the Biomedical Translational Research Information System (BTRIS, automatic for activities in the NIH CC).@@@@@@ (Summation)De-identified or identified data with approved outside collaborators under appropriate agreements.@@@@@@ (Summation)Data sharing may be complicated or limited in certain cases by contractual obligations or agreements with outside collaborators, such as cooperative research and development agreements, clinical trial agreements, other restraints, etc.|
Statistical Analysis Plan (SAP)
|Time Frame:||IPD and supporting information will be available after completion of the study. No end date.|
|Access Criteria:||Data will be shared through:@@@@@@ (Summation)BTRIS (automatic for activities in the NIH CC).@@@@@@ (Summation)Approved outside collaborators under appropriate individual agreements.@@@@@@ (Summation)Publication and/or public presentations.@@@@@@Data might be shared before publication.@@@@@@The PI will review all requests for sharing data.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Primary Immune Deficiency
Immune Defects of Phagocytes
Unusual, Chronic Bacterial, Mycobacterial, and Fungal Infections
Immunologic Deficiency Syndromes
Immune System Diseases