Enrolling by invitation

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Inflammation

Over 2 Years
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: June 1993

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: August 14, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 1993Actual date on which the first participant was enrolled.

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. 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.

Official TitleEvaluation and Long-Term Follow-Up of Patients With Acute or Chronic Inflammatory Disorders 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: August 14, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
500 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Other
Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 2 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Inflammation
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
immediate family members of patients with inflammatory conditions may be evaluated under this protocol
Group II
Inflammatory conditions associated with, but not limited, to acute and chronic infections or presumed infections, and congenital or acquired immunologic disorders
Study Objectives
Primary Objectives

screening of patients for other protocols,

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institutes of Health Clinical CenterBethesda, United StatesSee the location

Enrolling by invitationOne Study Center