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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001351
Recruitment Status : Enrolling by invitation
First Posted : November 4, 1999
Last Update Posted : November 2, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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.

Condition or disease
Immunologic Disorders Host Response Infectious Diseases

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 pathogenesis of these various disorders are being investigated under a number of NIAID clinical research protocols. This protocol is an evaluation and long-term follow protocol of such disorders for the purposes of maintaining a group of patients on which LCID investigators draw for our other various protocols. The patients admitted under this protocol also provide training and experience for members of the NIAID infectious diseases and allergy and immunology fellowship training programs as well as to provide a mechanism for the members of the Laboratory of Clinical Infectious Diseases to maintain their clinical skills. It is anticipated that the patients will receive a degree of clinical evaluation, care and monitoring more extensive than that generally available and that specimens collected from them can sometimes be used for laboratory studies related to inflammatory conditions. 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.

Study Type : Observational
Actual Enrollment : 293 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation and Long Term Follow Up of Patients With Acute or Chronic Inflammatory Disorders
Study Start Date : February 5, 1993

Primary Outcome Measures :
  1. Evaluation of patients [ Time Frame: at all visits ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Males and females ages 1 year to 80 years are eligible.

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.

Willingness to participate in clinical protocols when appropriate.

Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders.

Willingness to provide tissue samples for studying immune dyregulation and for genetic analysis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001351

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Adriana R Marques, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00001351     History of Changes
Other Study ID Numbers: 930086
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 31, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Chronic Infection
Infectious Diseases
Host Response
Immunologic Disorders
Acute Infection

Additional relevant MeSH terms:
Communicable Diseases
Immune System Diseases
Pathologic Processes