Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001351
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-15
First Post:
2006-07-12
Brief Title:
Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation and Long-Term Follow-Up of Patients With Acute or Chronic Inflammatory Disorders
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10-01
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 inflammatory diseases and disorders Inflammation is the body s immune response to many things including infections and other acute or chronic irritants It may also be a sign of abnormal immune function This study will allow evaluation and long-term follow-up of such disorders to
Establish and maintain a group of patients that may be eligible for other NIAID protocols
Provide clinical training and experience for NIAID fellows
Provide a mechanism for NIAID staff to maintain their clinical skills
Serve as a starting point for new investigations of syndromes not currently under study
Patients between 1 and 80 years of age with acute or chronic inflammation including but not limited to viral fungal or bacterial infections or abnormal immune responses may be eligible for this study Immediate family members of patients may also be enrolled for preliminary examination to see if they are affected in any way that may warrant further investigation
All patients and family members will have a history physical examination and laboratory tests Depending on the results family members may require additional tests Patients will have additional diagnostic tests indicated for their specific disease according to accepted medical standards These may include routine blood and urine tests X-rays or other imaging studies body fluid or tissue cultures skin tests for allergic or immune responses and others as needed
Treatments will include only medications approved by the Food and Drug Administration according to accepted dose schedules and delivery methods
Patients may be requested to donate extra blood for research studies No more than 450 cc 30 tablespoons will be drawn from adults within a 6-week period and no more that 7 cc 12 tablespoon from children under 18 years of age in the same time period
Establish and maintain a group of patients that may be eligible for other NIAID protocols
Provide clinical training and experience for NIAID fellows
Provide a mechanism for NIAID staff to maintain their clinical skills
Serve as a starting point for new investigations of syndromes not currently under study
Patients between 1 and 80 years of age with acute or chronic inflammation including but not limited to viral fungal or bacterial infections or abnormal immune responses may be eligible for this study Immediate family members of patients may also be enrolled for preliminary examination to see if they are affected in any way that may warrant further investigation
All patients and family members will have a history physical examination and laboratory tests Depending on the results family members may require additional tests Patients will have additional diagnostic tests indicated for their specific disease according to accepted medical standards These may include routine blood and urine tests X-rays or other imaging studies body fluid or tissue cultures skin tests for allergic or immune responses and others as needed
Treatments will include only medications approved by the Food and Drug Administration according to accepted dose schedules and delivery methods
Patients may be requested to donate extra blood for research studies No more than 450 cc 30 tablespoons will be drawn from adults within a 6-week period and no more that 7 cc 12 tablespoon from children under 18 years of age in the same time period
Detailed Description:
Inflammatory disorders including but not limited to those caused by viral bacterial fungal and parasitic infections and those associated with aberrant immunologic responses are exceedingly common acute and chronic disorders affecting humans The pathogeneses of these various disorders are being investigated under a number of NIAID clinical research protocols This protocol is an evaluation and long-term follow-up protocol of such disorders for the purposes of maintaining a group of patients on which LCIM investigators draw for our other various protocols Also this protocol may serve as a start point to studies of syndromes or diseases not being addressed by specific protocols and therefore can be used to evaluate family members of patients with inflammatory conditions when appropriate in order to try to understand further the disease before embarking in a specific protocol It is anticipated that the patients will receive a degree of clinical evaluation care and monitoring more extensive that that generally available and that specimens collected from them can sometimes be used for laboratory studies related to inflammatory conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 93-I-0086 | None | None | None |