*nih.life
			Clinical Trial Sponsors: National Institutes of Health Clinical Center (CC)

  Source:		NCT01200953


    		Admission and Management of Occupational
     		or Other Exposures to Biodefense/Bioterrorism
			Agents or to Epidemic/Emerging Infectious
			Diseases

			Recruiting

			First Update September 11, 2010
			Last Update January 24, 2020

			Brief Summary
			Background: - 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.
			Objectives: - 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.
			Eligibility: - 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. Design: - 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.

			Detailed Description
			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) and other infectious diseases, along
			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 rarely occur. The primary
			purpose of this protocol is to apply standardized,
			documented, and carefully monitored evaluation
			and prophylactic and treatment measures in
			the event of suspected or confirmed exposure
			to the causative agent of any disease of
			bioterrorism concern (whether of natural or
			deliberate origin), to agents under study in
			biodefense-related research laboratories, or
			to emerging infectious disease pathogens.
			Other goals include the characterization of
			natural history and clinical course of such
			diseases via the evaluation of close contacts
			of potentially exposed persons, as well as
			those who have recovered from illness; the
			elucidation of the pathophysiology of such
			diseases; the characterization of immune
			responses to such diseases; and the evaluation
			of diagnostic tests for the rapid identification
			of the causative agents of such diseases in
			clinical specimens. 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.

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