Diagnosis and Management of Inflammatory and Infectious Diseases

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....

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Infection

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

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Rosemary McConnell, R.N.; Phone Number: (301) 761-6645; Email: rosemary.mcconnell@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with an inflammatory or infectious condition are evaluated.

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Patients with a variety of infections and inflammatory diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H&P, labs and other clinical metrics	this is a hypothesis-generating training consult protocol	initial and follow-up clinic visits

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Mary E Wright, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 1978

Study Registration Dates

• First Submitted: November 10, 2007
• First Submitted That Met QC Criteria: November 10, 2007
• First Posted (Estimated): November 14, 2007

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: May 24, 2023

More Information

Terms related to this study

• Keywords: Inflammation; Infection; Natural History; Fever
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Inflammation; Infections; Communicable Diseases
• Other Study ID Numbers: 780023; 78-I-0023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No