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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00001351
First received: July 12, 2006
Last updated: October 7, 2014
Last verified: September 2014
  Purpose

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
Immunologic Disorders
Host Response
Infectious Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation and Long Term Follow Up of Patients With Acute or Chronic Inflammatory Disorders

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Evaluation of patients [ Time Frame: at all visits ] [ Designated as safety issue: No ]

Enrollment: 289
Study Start Date: February 1993
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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITIERIA:

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001351

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

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00001351     History of Changes
Other Study ID Numbers: 930086, 93-I-0086
Study First Received: July 12, 2006
Last Updated: October 7, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 16, 2014