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Protocol Details

Evaluation and Long-Term Follow-Up of Patients with Acute or Chronic Inflammatory Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

93-I-0086

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 2
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Keywords

Human;
Disease;
Infection;
Immunology;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Inflammation

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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Eligibility

INCLUSION CRITIERIA:

-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.

-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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Adriana R. Marques, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 12C118
10 CENTER DR
BETHESDA MD 20892
(301) 435-7244
amarques@niaid.nih.gov

Adriana R. Marques, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 12C118
10 CENTER DR
BETHESDA MD 20892
(301) 435-7244
lymedxstudies@niaid.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00001351

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