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RecruitingNCT00557726Updated Nov 5, 2026

Diagnosis and Management of Inflammatory and Infectious Diseases

An observational study in Infection and Inflammation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 1 site in United States. Open to participants aged 3 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

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

From the registry’s dates

  • Started Feb 1978; still recruiting 48 years 8 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
400
Ages
3 Years to 100 Years
Sex
All
01

Study summary

This protocol is being established to cover the evaluation of patients with inflammatory and/or infectious diseases which are not covered under previously existing protocols. The purpose of such a protocol is that frequently patients are referred to us with either diagnosed or undiagnosed illnesses which would be of interest to our teaching program or which would serve as a source of patients to subsequently be entered into established, ongoing protocol studies. Such patients will be admitted to the protocol and handled according to accepted medical practice of diagnosis and treatment.

Read the detailed description

Study Description:

This protocol was established in 1978 to evaluate patients with diagnosed and undiagnosed inflammatory and/or infectious diseases that are of scientific interest. Once diagnosis is made patients are referred to relevant NIH protocols for follow-up. If an NIH protocol does not exist for the condition, participants receive the required clinical standard of care treatment through an outside provider or through this protocol if a provider with the necessary expertise cannot be found. It is a minimal risk study.

Objective:

To evaluate patients with possible infectious and/or inflammatory diseases in order to collect data/samples through the diagnosis of infectious and inflammatory conditions (including in terms of clinical, immunologic, and metabolic features) further characterize, and treat infectious and inflammatory conditions through the collection of clinical specimens, medical records and in-person assessments

To provide a repository of information on enrolled participants to allow for hypothesis generation in future research

02

Conditions studied

  • Infection
  • Inflammation

Keywords

  • Inflammation
  • Infection
  • Fever
  • Natural History
03

In context

Infections

2,093 studies on the registry are indexed under Infections; 364 are open to participants now.

This study's planned enrollment of 400 is above the median of 300 across 685 observational studies indexed under Infections.

Browse Infections 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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals with an inflammatory or infectious condition are evaluated.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Known or suspected exposure to infection, as determined by the Principal Investigator OR Presence of signs and symptoms of an infectious or inflammatory disease

    1. Age range: 3 years of age and older.
    2. NIAID/LIR investigator who 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.
    3. Primary physician outside the NIH
    4. The patient or the patient's Legally Authorized Representative is capable of and signs the consent form. The consent form will be signed by parents or guardians of patients under the age of 18

Exclusion criteria

EXCLUSION CRITERIA:

  1. Pregnant.
  2. Presence of conditions that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.
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
Other
Enrollment
400 participants (estimated)

Groups and cohorts

  • 1

    Patients with a variety of infections and inflammatory diseases.

06

What researchers measure

Primary outcomes

  1. H&P, labs and other clinical metrics

    this is a hypothesis-generating training consult protocol

    Time frame: initial and follow-up clinic visits

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Individual results and Physician's notes will be shared with Primary Care Providers as identified by the study participant.

09

Timeline

4 registry updates since Sep 25, 2026

Started Feb 1978 (actual).

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

Registered
Nov 10, 2007
First posted
Nov 14, 2007
StartActual
Feb 17, 1978
Last update
Nov 5, 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.
Minor edits
Nothing that changes what the study is or who can join. Edited: description and verification date
4 updates, last Nov 5, 2026
Show all 4 updates
  1. Nov 5, 2026
    Minor edits only
    + 1 other change: verification date
  2. Oct 29, 2026
    Minor edits only
    + 1 other change: verification date
  3. Oct 16, 2026
    Minor edits only
    + 1 other change: description
  4. Oct 13, 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
NCT00557726
Responsible party
Sponsor
First posted
Nov 14, 2007
Start date
Feb 17, 1978
Last update
Nov 5, 2026

Study contacts

Rosemary McConnell, R.N.
Contact
rosemary.mcconnell@nih.gov
(301) 827-9716
Mary E Wright, 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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