Evaluation and Treatment of Severe Acute Respiratory Syndrome (SARS)
| Status: | Withdrawn |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2003 |
| End Date: | December 2010 |
Clinical Evaluation and Management of Persons With Severe Acute Respiratory Syndrome (SARS)
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
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
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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