Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073086
Status:
WITHDRAWN
Last Update Posted:
2017-07-02
First Post:
2003-11-14
Brief Title:
Evaluation and Treatment of Severe Acute Respiratory Syndrome SARS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical Evaluation and Management of Persons With Severe Acute Respiratory Syndrome SARS
Status:
WITHDRAWN
Status Verified Date:
2010-12-27
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-I-0030 | None | None | None |