Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders

NCT00001351 | Enrolling By Invitation

• 2 other identifiers: 93008693-I-0086
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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 (1/2 tablespoon) from children under 18 years of age in the same time period. ...

Conditions

Inflammation

Keywords

Human; Disease; Infection; Immunology; Natural History

Outcome Measures

Primary Outcomes (2)

• screening of patients for other protocols

  screening of patients for other protocols,

  ongoing through the study

• evaluation and follow-up of interesting patients, who do not fit in our other protocols

  evaluation and follow-up of interesting patients, who do not fit in our other protocols

  ongoing through the study

Study Arms (2)

Immediate family members of patients

immediate family members of patients with inflammatory conditions may be evaluated under this protocol

Patients

Inflammatory conditions associated with, but not limited, to acute and chronic infections or presumed infections, and congenital or acquired immunologic disorders

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- Inflammatory conditions associated with, but not limited, to acute and chronic infections or presumed infections, and congenital or acquired immunologic disorders@@@- If appropriate, immediate family members of patients with inflammatory conditions may be evaluated under this protocol, as a preamble to see if further investigation is warranted, what would be done under a specific protocol.

* INCLUSION CRITIERIA: * Males and females ages 2 years and older. * Inflammatory conditions associated with, but not limited, to acute and chronic infections or presumed infections, and congenital or acquired immunologic disorders, as determined by the principal or associated investigators. * A NIAID/LCIM investigator has an interest in the patient s illness and is willing to serve as attending physician to supervise the patient's medical care at the NIH. * If appropriate, immediate family members of patients with inflammatory conditions may be evaluated under this protocol to determine if they may also be affected by their relative s disease. * Willingness to participate in clinical protocols when appropriate. * Subjects must maintain a primary physician outside NIH for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders. * Willingness to have samples stored and to provide tissue samples for studying immune dysregulation and for genetic analysis. * Ablility to provide informed consent or, for the patient cohort, has a designated legally authorized representative (LAR). * For females, not pregnant.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Inflammation; Disease; Infections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adriana R Marques, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: November 4, 1999
• Study Start: June 1, 1993
• Last Updated: May 1, 2026

Record last verified: 2025-12-15

Locations

US (1)