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Investigating Severe Acute Respiratory Syndrome (SARS)



Investigating Severe Acute Respiratory Syndrome (SARS)

For Condition: SARS Virus
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Severe Acute Respiratory Syndrome (SARS) is a newly recognized illness that can be fatal. The purpose of this study is to better understand SARS by collecting samples of blood and other body fluids of people who have been exposed to SARS or who are suspected to have the illness. Up to 300 volunteers aged 18 years or older will be enrolled in this study. Participants will donate blood samples and, if appropriate, samples of fluid from the lungs, nose, or throat. Researchers will test these samples for proteins that control or mediate inflammatory or immune responses. The patterns of these proteins will reveal how SARS affects the body and the efforts the body makes to fight off the infection.
Details: Severe acute respiratory syndrome (SARS) is a newly recognized illness associated with substantial mobidity and mortality. Patients develop fever followed by rapidly progressive and even fatal respiratory disease. SARS is associated with infection with a novel coronavirus. The evaluation of the inflammatory responses evoked by SARS may yield information regarding its pathogenesis and help with patient management. This protocol, then, merely aims to study disease pathogenesis and natural history, by studying samples and data that are collected by outside physicians or physicians at the Clinical Center and sent for evaluation of the inflammatory response.
Eligibility:
Study Type:  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Cases: Patients fulfilling the CDC case definition or WHO definition for suspected or probably SARS. Newly identified patients found to have recovered from SARS can also be enrolled. Healthy Volunteers: A healthy volunteer is defined as a healty male or female, age 18 and above. Volunteers will be excluded if they have a pre-existing concurrent serious chronic medical or psychiatric illness. Chronic medication use will be evaluated on a case by case basis. They will also be excluded if they have received an investigational drug in the past 3 months. EXCLUSION CRITERIA: Patients diagnoses with alternative illnesses as the cause of the symptoms.
Total Enrollment: 400

Location and Contact Information:

National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patient  and Public Liaison Office 1-800-411-1222


Additional Information:
Study ID Numbers:  030240;  03-I-0240
Study Start Date: August 4, 2003
Record last reviewed: June 25, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066209

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