Clinical trial NCT00557726: Diagnosis and Management of Inflammatory and Infectious Diseases
Official title: Diagnosis and Management of Inflammatory and Infectious Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infection
Inflammation
Keywords: Inflammation
Infection
Fever
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2007-11-14
Enrollment: 400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with an inflammatory or infectious condition are evaluated.

Brief 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.

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

Eligibility criteria: * 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.

Primary outcomes:
measure: H&amp;P, labs and other clinical metrics
timeFrame: initial and follow-up clinic visits
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Mary E Wright, M.D.
role: PRINCIPAL_INVESTIGATOR
References: