Diagnosis and Management of Inflammatory and Infectious Diseases

Inflammation Clinical Trial

Official title:

Diagnosis and Management of Inflammatory and Infectious Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00557726
• Other study ID #: 780023
• Secondary ID: 78-I-0023
• Status: Recruiting
• Start date: February 17, 1978

Study information

• Verified date: May 10, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Rosemary McConnell, R.N.
• Phone: (301) 761-6645
• Email: rosemary.mcconnell[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections
• Inflammation

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H&P, labs and other clinical metrics	this is a hypothesis-generating training consult protocol	initial and follow-up clinic visits

External Links

•   NIH Clinical Center Detailed Web Page