InflammationNCT00001351
Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders
An observational study of Inflammation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Inflammation
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 1993to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Evaluation and Long-Term Follow-Up of Patients With Acute or Chronic Inflammatory Disorders
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.
Read more
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.
- Conditions
- Inflammation
- Keywords
- Human, Disease, Infection, Immunology, Natural History
- Medical subject headings
- Inflammation, Disease, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening of patients for other protocols
screening of patients for other protocols,
Measured: 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
Measured: ongoing through the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start1 Jun 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Adriana R Marques, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001351
- Sponsor's protocol ID
- 930086
- Other IDs
- 93-I-0086
- Status last verified
- 25 Sep 2026
- First submitted
- 12 Jul 2006
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Long-Term Follow-Up of Patients With Acute or Chronic Inflammatory Disorders
- ClinicalTrials.gov ID
- NCT00001351
- Acronym / sponsor ID
- 930086
- Conditions
- Inflammation
- Keywords
- Human, Disease, Infection, Immunology, Natural History
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 1 Jun 1993 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
screening of patients for other protocols
Time frame: ongoing through the study
screening of patients for other protocols,
evaluation and follow-up of interesting patients, who do not fit in our other protocols
Time frame: ongoing through the study
evaluation and follow-up of interesting patients, who do not fit in our other protocols
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adriana R Marques, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
screening of patients for other protocols (time frame: ongoing through the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.