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Evaluation and Treatment of Severe Acute Respiratory Syndrome (SARS)
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), January 2009
First Received: November 14, 2003   Last Updated: September 3, 2009   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00073086
  Purpose

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 twi...

Condition
Severe Acute Respiratory Syndrome

Study Type: Observational
Official Title: Clinical Evaluation and Management of Persons With Severe Acute Respiratory Syndrome (SARS)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 200
Study Start Date: November 2003
Estimated Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Since mid February 2003, there have been reports of atypical pneumonias originating in China which have subsequently been termed the Severe Acute Respiratory Syndrome (SARS). SARS has subsequently spread to multiple countries including the United States, and is accompanied by a higher than anticipated morbidity and mortality. Because of world travel and the apparent easy transmissibility of this disease reported in other nations, the number of patients with SARS may continue to rise. The primary purpose of this protocol is to evaluate and treat persons with SARS. Other goals will be to characterize the clinical course of SARS by also evaluating close contacts of people with SARS, as well as those that have recovered from SARS. Additional goals of the protocol are to elucidate the pathophysiology of SARS, characterize the immune response during SARS, and evaluate diagnostic tests for the rapid identification of SARS in clinical specimens. Further knowledge about SARS may lead to effective forms of therapy and improve mortality from this disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Probable SARS Inclusion Criteria:

  1. 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)

    OR

    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

  2. Measured temperature greater than 100.4(Degree)F (greater than 38(Degree) C)

    AND

  3. Evidence of an acute respiratory illness as manifested by one of the following:

    Cough: shortness of breath, difficulty breathing, hypoxia

    AND

  4. Radiographic evidence of pneumonia or ARDS

    AND

  5. Clinically stable for transfer to the Clinical Center

    AND

  6. 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.

Suspected SARS Inclusion Criteria:

  1. One of the following:

    1. Travel within 14 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)

      OR

    2. Close contact within 14 days of onset of symptoms with either a person with a respiratory illness who traveled to a SARS area or a person known to be a suspect SARS case.

    Close contact is defined as one of the following:

    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.

    Other contact of sufficient proximity and duration that transmission of the causative agent of SARS may have occurred. This will be determined on an individual basis by the PI or an associate investigator.

    AND

  2. One of the following:

    1. Measured temperature greater than 100.4(Degree)F (greater than 38(Degree) C)
    2. Evidence of an acute respiratory illness as manifest by one of the following:

    cough, shortness of breath, difficulty breathing, hypoxia, radiographic findings of either pneumonia or acute respiratory distress syndrome

    AND

  3. Clinically stable for transfer to the Clinical Center

    AND

  4. 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.

Close Contact Inclusion Criteria:

  1. Close contact with a patient suspected to have SARS within 10 days of the time of enrollment.

    Close contact is defined as one of the following:

    having cared for, having lived with, or having direct contact with respiratory secretions and/or body fluids of a patient suspected or known to have SARS.

    Other contact of sufficient proximity and duration that transmission of the causative agent of SARS may have occurred. This will be determined on an individual basis by the PI or an associate investigator.

    AND

  2. 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 signed by a legal guardian or appropriate proxy.

Recovered SARS Inclusion Criteria

1. Within the last six months, had one of the following:

  1. an acute illness characterized by (all of the following):

    1. Fever greater than 100.4 (if measured)

      AND

    2. History of an acute respiratory illness as manifested by one of the following:

      cough, shortness of breath, difficulty breathing, hypoxia

      AND

    3. The illness occurred within 10days of travel to an area with documented or suspected community transmission of SARS (as continually defined by the WHO and/or CDC)

    OR

    Had close contact within 10 days of onset of symptoms with either a person with a respiratory illness who traveled to a SARS area or a person known to be a suspected SARS case.

    Close contact is defined as one of the following:

    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.

    Other contact of sufficient proximity and duration that transmission of the causative agent of SARS may have occurred. This will be determined on an individual basis by the PI or an associate investigator.

    OR

  2. an acute respiratory illness with the laboratory confirmation of SARS

    AND

    2. 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 signed by a legal guardian or appropriate proxy.

    Health Care Worker Surveillance Inclusion Criteria

    1. NIH health care worker that is anticipated to be involved with the clinical care of SARS patients
    2. The ability to understand and willingness to sign a written consent form.

    A health care worker is defined as anyone involved with patient care or patient contact.

    Note: this group may be enrolled prior to SARS patients hospitalized at the clinical center.

    EXCLUSION CRITERIA:

    Probable SARS Exclusion Criteria:

    1. Age less than 18 years old.
    2. Known pregnancy or positive urine/blood pregnancy test.

    Suspected SARS Exclusion Criteria:

    1. Meets inclusion criteria for SARS
    2. Age less than 18 years old.
    3. Known pregnancy or positive urine/blood pregnancy test.

    Close Contact Exclusion Criteria:

    1. Less than 10 kg.
    2. Subjects who meet criteria for SARS or Suspected SARS

    Recovered SARS Exclusion Criteria

    1. Less than 10 kg.
    2. Temperature greater than 100.4 F (38.0 C) or symptoms of active respiratory illness

    Health Care Worker Surveillance Exclusion Criteria

    No exclusion criteria.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073086

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 040030, 04-I-0030
Study First Received: November 14, 2003
Last Updated: September 3, 2009
ClinicalTrials.gov Identifier: NCT00073086     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Coronavirus
Pneumonia
Asia
China
Coronavirus
Pneumonia
Severe Acut Respiratory Syndrome
SARS
Suspected SARS

Additional relevant MeSH terms:
Virus Diseases
Severe Acute Respiratory Syndrome
RNA Virus Infections
Nidovirales Infections
Coronavirus Infections
Pathologic Processes
Disease
Respiratory Tract Diseases
Respiratory Tract Infections
Syndrome
Coronaviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009