Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001257
Status:
TERMINATED
Last Update Posted:
2019-08-06
First Post:
1999-11-03
Brief Title:
Inflammatory Responses in Normal Volunteers and Patients With Abnormal Immune Responses
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Comparison of Inflammatory Responses in Normal Volunteers and Patients With Abnormal Phagocyte Function Using the Suction Blister Technique
Status:
TERMINATED
Status Verified Date:
2019-08-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Patients with abnormal regulation of inflammation and with host defense defects often have an exaggerated or depressed inflammatory response with resultant difficulty in healing of recurrent infections Delayed healing can be manifested by either a delay in wound healing granuloma formation along the incision line or dehiscence of a partially healed wound without evidence of infection We are interested in studying the dynamics of host immune defenses during an experimentally induced inflammatory response using a well-studied suction blister device This protocol is designed to study mediators of inflammation in patients with host defense defects as well as patients with excessive inflammation as in the vasculitis syndromes We will measure mediators of inflammation eg C5a leukotriene B4 interleukins chemokines tumor necrosis factor interferon-gamma by ELISA radioimmunoassay High Performance Liquid Chromatography multiplex cytokine assays andor bioactivity assays Furthermore molecular characterization and host defense functions eg respiratory burst chemotaxis phagocytosis microbicidal activity of cells recruited to the blisters will also be examined In addition to the analysis of cell function RNA will be prepared and subject to DNA microarray or quantitative RT-PCR studies to measure expression and dynamics of key inflammatory mediators Many of these factors contribute to the inflammatory process and several are thought to be important in granuloma formation If patients are found to have abnormal amounts of these mediators when compared to healthy volunteers or patients with other abnormalities it will help us understand the basis for their disease and new therapeutic strategies For example this blister study allowed us to identify a patient subsequently shown to have IRAK4 deficiency
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 90-I-0120 | None | None | None |