Evaluation and Treatment of Severe Acute Respiratory Syndrome (SARS)

NCT00073086 | Withdrawn

• 2 other identifiers: 04003004-I-0030
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate and treat people with SARS, a new type of pneumonia (lung infection) originating in China. SARS is caused by a new virus that is easily transmitted from person to person. This study will look at the course of the disease; determine how the virus affects the body and how the body fights the infection; and evaluate diagnostic tests to quickly identify the disease. People 18 years of age and older with probable or suspected SARS may be eligible for this study. Close contacts of patients with SARS, patients who recovered from SARS, and NIH health care workers involved in the care of patients will also be enrolled. Patients with SARS who require hospitalization will be admitted to the NIH Clinical Center. Because SARS spreads easily, hospitalized patients will be in a room by themselves and will not be allowed any visitors. They will not leave their room except for tests, such as x-rays. All participants will have a full medical examination, including a medical history, physical examination, and blood tests. In addition, the participants undergo various tests and procedures as follows:

• Probable and suspected SARS patients may be hospitalized or may be seen as outpatients. They are provided the treatment judged best for their disease, usually according to expressed or published recommendations. The best treatment for SARS is not yet known, and there have been no studies evaluating therapies. Outpatients are seen three times a week for 2 weeks, once a week for 4 more weeks, and then at 6 months. Patients have mouth and throat swabs taken three times a week for the first 2 weeks, then once a week for 4 more weeks. Blood is drawn three times a week for the first 2 weeks, then once at weeks 3, 4, and 6. If virus is still detectable after 6 weeks, nose washings and throat swabs are repeated until no virus is detected for 3 weeks in a row. In addition, patients provide urine and stool samples, have a chest x-ray and electrocardiogram, and undergo bronchoscopy and bronchial lavage. For the bronchoscopy, a bronchoscope (pencil-thin flexible tube) is passed into the large airways of the lung, allowing the physician to examine the airways. Cells and secretions from the airways are rinsed from the lung with salt water. A brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways and pieces of tissue are collected for analysis.
• Close contacts of patients are evaluated twice a week for 2 weeks, then once a week for 2 more weeks. Blood is drawn at the first visit and then at 1, 2, and 4 weeks. Mouth and throat swabs, nose washings, and sputum collections are done twice a week for 2 weeks, then once a week for 2 more weeks. Urine and stool samples are collected once a week for 4 weeks. If virus from the nose or throat is still detectable after 4 weeks, weekly nose washings and throat swabs continue until no virus is detected for 3 weeks in a row. Blood may also be drawn during the weekly visits.
• Recovered SARS patients provide blood, urine, and stool samples and have a mouth and throat swab and nose aspiration to see if the SARS virus is present. For the nasal aspiration, salt water is put in the nose and then suctioned out. Usually, these tests are done only once. If virus is detected, however, the nose washing, throat swabs and blood tests are repeated once a week until no virus is detected for 3 weeks in a row.
• Health care workers document their contact with patients, use of isolation procedures and equipment, and any unexpected events that occur during contact. They are evaluated for symptoms of infection and provide a blood sample once a month

Conditions

Severe Acute Respiratory Syndrome

Keywords

Coronavirus; Pneumonia; Asia; China; Severe Acut Respiratory Syndrome; SARS; Suspected SARS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One of the following:
• Travel within 10 days of onset of symptoms to an area with documented or suspected community transmission of SARS (as continually defined by the WHO and/or CDC)
• Close contact within 10 days of onset of symptoms with a person known to be a suspect SARS case.
• Close contact is defined as having cared for, having lived with, or having direct contact with respiratory secretions and/or body fluids of a patient known to be suspect SARS case.
• AND
• Measured temperature greater than 100.4(Degree)F (greater than 38(Degree) C)
• AND
• Evidence of an acute respiratory illness as manifested by one of the following:
• Cough: shortness of breath, difficulty breathing, hypoxia
• AND
• Radiographic evidence of pneumonia or ARDS
• AND
• Clinically stable for transfer to the Clinical Center
• AND
• The ability to understand and willingness to sign a written consent form or in cases of 1) a minor, 2) temporary incompetence due to severe illness, or 3) permanent incompetence due to a chronic condition, informed consent may be signed by a legal guardian or appropriate proxy.

You may not qualify if:

• Age less than 18 years old.
• Known pregnancy or positive urine/blood pregnancy test.
• Age less than 18 years old.
• Known pregnancy or positive urine/blood pregnancy test.
• Less than 10 kg.
• Subjects who meet criteria for SARS or Suspected SARS
• Less than 10 kg.
• Temperature greater than 100.4 F (38.0 C) or symptoms of active respiratory illness

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Centers for Disease Control and Prevention (CDC). Update: Outbreak of severe acute respiratory syndrome--worldwide, 2003. MMWR Morb Mortal Wkly Rep. 2003 Mar 28;52(12):241-6, 248.

  PMID: 12680518 BACKGROUND

• Gilbert BE, Knight V. Biochemistry and clinical applications of ribavirin. Antimicrob Agents Chemother. 1986 Aug;30(2):201-5. doi: 10.1128/AAC.30.2.201. No abstract available.

  PMID: 2876677 BACKGROUND

• Stein DS, Creticos CM, Jackson GG, Bernstein JM, Hayden FG, Schiff GM, Bernstein DI. Oral ribavirin treatment of influenza A and B. Antimicrob Agents Chemother. 1987 Aug;31(8):1285-7. doi: 10.1128/AAC.31.8.1285.

  PMID: 3307623 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Coronavirus Infections; Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 14, 2003
• First Posted: November 17, 2003
• Study Start: November 5, 2003
• Study Completion: December 27, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-12-27

Locations

US (1)