Healthy Volunteers Clinical Trial
Official title:
Comparison of Inflammatory Responses in Normal Volunteers and Patients With Abnormal Phagocyte Function Using the Suction Blister Technique
Verified date | August 2, 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will investigate the inflammatory response. People with abnormal regulation of
inflammation and immune defects often have an exaggerated or depressed inflammatory response
that results in poor healing of recurrent infections. This study will measure and compare
amounts of inflammatory mediators (chemicals involved in the inflammatory response) in
healthy normal volunteers and in patients with abnormal immune responses.
Healthy normal volunteers and patients with host defense defects or excessive inflammation,
as in vasculitis syndromes, may be eligible for this study. Patients must be between 6 and 65
years of age.
Participants will have eight small blisters raised on the forearm using a gentle suction
device. The top of the blisters will be removed with scissors and a plastic template will be
placed over the blisters. The wells of the template will be filled with a salt solution or a
mixture of the subject s serum (fluid part of the blood without cells) and a salt solution.
Some blisters may be covered with coverslips a small round piece of very thin sterilized
glass before adding the fluid. Blister fluid will be removed from the wells at 3, 5, 8, and
24 hours with a syringe and analyzed for inflammatory mediators. A scab will form over the
blisters and fall off in about 2 weeks.
Participants will have about 4 tablespoons of blood drawn in order to compare the
inflammatory mediators in the blood with those in the blister fluid.
Status | Terminated |
Enrollment | 169 |
Est. completion date | August 2, 2019 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 65 Years |
Eligibility |
- INCLUSION CRITERIA - PATIENTS: Patients having or thought to have an immune defect between the ages of 6 and 65 years (inclusive) are eligible to participate. INCLUSION CRITERIA - NORMAL VOLUNTEERS: Be a healthy adult of either sex and between the ages of 18 and 65 years old. Weight greater than 110 pounds. Not have any heart, lung, or kidney disease, or bleeding disorders. Not have a history of viral hepatitis (B or C) since age 11. Not have a history of intravenous injection drug use. Not have a history of engaging in high-risk activities for exposure to the AIDS virus. Not be pregnant. EXCLUSION CRITERIA - PATIENTS: Patients less than 6 or greater than 65 years of age. EXCLUSION CRITERIA - NORMAL VOLUNTEER: Less than 18 years old or older than 65 years. Have viral hepatitis (B or C). HIV positive. Receiving chemotherapeutic agent(s), or have underlying malignancy. Pregnant. Have history of heart, lung, kidney disease, or bleeding disorders. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Dale DC, Wolff SM. Skin window studies of the acute inflammatory responses of neutropenic patients. Blood. 1971 Aug;38(2):138-42. — View Citation
Hellum KB, Solberg CO. Human leucocyte migration: studies with an improved skin chamber technique. Acta Pathol Microbiol Scand C. 1977 Dec;85C(6):413-23. — View Citation
Kuhns DB, Long Priel DA, Gallin JI. Loss of L-selectin (CD62L) on human neutrophils following exudation in vivo. Cell Immunol. 1995 Sep;164(2):306-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To identify mediators that contribute to the inflammatory process and granuloma formation by comparing mediators collected from healthy volunteers to patients with abnormal regulation of inflammation and patients with host defense defects. | Ongoing |
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