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Enrolling by invitationNCT00001351Updated Oct 29, 2026

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

An observational study in Inflammation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Enrolling by invitation at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Primary conditionInflammation(the registry's first term)UnverifiedIs this wrong?Inflammation is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Updated Sep 29, 2026Eligibility revisedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
500
Ages
2 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Inflammation

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Keywords

  • Human
  • Disease
  • Infection
  • Immunology
  • Natural History
03

In context

Inflammation Unverified

3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.

This study's planned enrollment of 500 is above the median of 100 across 864 observational studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Compared within Inflammation, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

The criteria were revised on the registry on Sep 29, 2026. See what changed

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

  • 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 or, for the patient cohort, has a designated legally authorized representative (LAR).
  • For females, not pregnant.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
500 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. screening of patients for other protocols

    screening of patients for other protocols,

    Time frame: ongoing through the study

  2. 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

    Time frame: ongoing through the study

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

09

Timeline

6 registry updates since Sep 25, 2026

Started Jun 1993 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2006
First posted
Nov 4, 1999
StartActual
Jun 1, 1993
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
2 criteria edited
What changed in the criteria
  • EditedA 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.
  • EditedIf 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.
Sep 29, 2026
Show all 6 updates
  1. Oct 29, 2026
    Minor edits only
    + 1 other change: description
  2. Oct 27, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 8, 2026
    Minor edits only
    + 1 other change: description
  4. Oct 2, 2026
    Minor edits only
    + 1 other change: verification date
  5. Sep 29, 2026
    Eligibility 2 criteria edited
    What changed in the criteria
    • EditedA 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.
    • EditedIf 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.
  6. Sep 28, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00001351
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
Jun 1, 1993
Last update
Oct 29, 2026

Study contacts

Adriana R Marques, M.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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