Protocol Details

Comparison of Inflammatory Responses in Normal Volunteers and Patients with Abnormal Phagocyte Function Using the Suction Blister Technique

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	90-I-0120
Sponsoring Institute	National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 6 Max Age: 65
Referral Letter Required	Yes
Population Exclusion(s)	None
Special Instructions	Currently Not Provided
Keywords	Lymphokines; LTB4; Inflammation
Recruitment Keyword(s)	Normal Volunteer; Abnormal Phagocyte Function
Condition(s)	Healthy; Inflammation; Vasculitis
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Allergy and Infectious Diseases

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.

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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.

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Citations:

Skin window studies in acute inflammatory responses of neutropenic patients

Increased cell-associated IL-8 in human exudative and A23187-treated peripheral blood neutrophils

Loss of L-selectin (CD62L) on human neutrophils following exudation in vivo

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Contacts:

Principal Investigator	Referral Contact	For more information:
Kol A. Zarember, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 5-3816 10 Center Drive Bethesda, Maryland 20892 (301) 402-1802 kz29m@nih.gov	Patricia L. Littel, R.N. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 5-5140 10 Center Drive Bethesda, Maryland 20892 (301) 402-5964 plittel@cc.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00001257

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