Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01200953|
Recruitment Status : Recruiting
First Posted : September 14, 2010
Last Update Posted : November 13, 2020
- Increased clinical attention has been paid to the evaluation and management of bioterrorism-related illness (such as anthrax infection) and emerging infectious diseases (such as Severe Acute Respiratory Syndrome [SARS] and new strains of influenza). However, evaluation and treatment data for these illnesses are often limited because human infections to date have been relatively limited. Further knowledge about diseases of bioterrorism concern and emerging infectious diseases may lead to more effective forms of therapy to prevent disease-related illnesses and deaths.
- To apply standardized, documented, and carefully monitored evaluation and treatment methods for bioterrorism- and biodefense-related illnesses and emerging infectious diseases at the National Institutes of Health Clinical Center.
- Individuals at least 2 years of age who have confirmed or suspected infection by a biodefense or bioterrorism agent, or an emerging infectious disease agent.
- Individuals at least 2 years of age who have confirmed or suspected exposure to a biodefense or bioterrorism agent, an emerging infectious disease agent, or who have close exposure to an individual who is suspected of being infected with one of these agents.
- Health care workers who are involved in medical treatment of the abovementioned infected or exposed individuals.
- All eligible persons will have an initial screening evaluation to determine the circumstances of possible infectious exposure (e.g., where, when, and how exposed), current medical condition and medical care given, and any aspects of medical history that might be relevant to the exposure.
- Participants may be seen in an outpatient clinic or in the Special Clinical Studies Unit (SCSU) at the National Institutes of Health (NIH). The NIH SCSU is a hospital ward specially designed to minimize the risk of spreading infection to others.
- Upon admission, participants will provide blood and urine samples, have an electrocardiogram to measure heart activity, and have specific tests or procedures associated with the particular infectious agent.
- Participants who develop illnesses will be treated with the standard of care for known diseases or with experimental measures, depending on the nature of the illness. Separate consent may be required for these treatments.
- Participants will remain on this study for at least 1 year following the period of active evaluation and treatment. Participants may be asked to come to the NIH outpatient clinic on a periodic basis for medical evaluations and blood tests, and may be asked to keep a diary card to record any unusual signs or symptoms of possible infection.
|Condition or disease|
|Occupational Accidents Incubation Period, Infectious Disese|
Since the fall 2001 distribution of letters containing Bacillus anthracis spores via the US postal system, increased attention has been paid to the evaluation and management of bioterrorism-related illness. Similarly, the emergence of Severe Acute Respiratory Syndrome (SARS) in 2003, the Middle East Respiratory Syndrome (MERS) in 2012, Ebola virus disease in both 2013-16 and 2018-20, and, most recently, the global advent of SARS-CoV-2 infections in 2019, coupled with the ongoing threat of global influenza pandemics, have fostered intensive interest in the evaluation and management of emerging infections both in the US and internationally. Data to this end are often limited, however, in that while many such diseases exist in nature, human illness may only occur rarely or sporadically. The primary purpose of this protocol is to characterize the clinical course and determine the underlying pathophysiology of infection with the causative agent of any disease of bioterrorism concern (whether of natural or deliberate origin), agents under study in biodefense-related research laboratories, or emerging infectious disease pathogens of public health concern via the evaluation of infected or exposed persons, close contacts of potentially infected or exposed persons, as well as those who have recovered from illness. Other goals include the characterization of immune responses to such diseases; the evaluation of diagnostic tests for the rapid identification of the causative agents of such diseases in clinical specimens; and the
observation, follow-up, and simulation training of medical staff involved in the care of the above categories of patients. The ultimate goal is that further knowledge about diseases of bioterrorism concern and emerging infectious diseases may lead to more effective forms of therapy and improve disease-related morbidity and mortality.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases|
|Actual Study Start Date :||August 4, 2011|
Confirmed or suspected exposure
Confirmed or suspected exposure to biodefense select agent, to agent of bioterrorism concern, to naturally-occurring pathogen in the environment, to EID agent, or to an individual
Confirmed or suspected infection
Confirmed or suspected infection by biodefense select agent, by agent of bioterrorism concern, by naturally-occurring pathogen in the environment, or by emerging infectious disease agent
Healthcare worker or healthy volunteer
Healthcare worker or healthy volunteer involved in simulation drills or exercises evaluating the Clinical Center admission, care, and infection control processes
Healthcare worker surveillance
Healthcare worker surveillance of medical staff involved in the medical care of patients in the above 2 categories
- Symptoms and signs [ Time Frame: 1 year ]Determination of sustained absence of disease-specific symptoms and signs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200953
|Contact: Richard T Davey, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Richard T Davey, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|