Inflammatory Responses in Normal Volunteers and Patients With Abnormal Immune Responses

NCT00001257 | Terminated

• 2 other identifiers: 90012090-I-0120
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers; Abnormal Phagocyte Function

Keywords

Lymphokines; LTB4; Inflammation; Normal Volunteer; Abnormal Phagocyte Function

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having or thought to have an immune defect between the ages of 6 and 65 years (inclusive) are eligible to participate.
• 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.

You may not qualify if:

• Patients less than 6 or greater than 65 years of age.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Dale DC, Wolff SM. Skin window studies of the acute inflammatory responses of neutropenic patients. Blood. 1971 Aug;38(2):138-42. No abstract available.

  PMID: 4933314 BACKGROUND

• 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. doi: 10.1111/j.1699-0463.1977.tb03663.x.

  PMID: 343498 BACKGROUND

• 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. doi: 10.1006/cimm.1995.1174.

  PMID: 7544694 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kol A Zarember, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: April 24, 1990
• Study Completion: August 2, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-08-02

Locations

US (1)