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

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ClinicalTrials.gov Identifier: NCT01200953
Recruitment Status : Recruiting
First Posted : September 14, 2010
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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.

Condition or disease
Occupational Accidents Incubation Period, Infectious Disese

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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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Symptoms and signs [ Time Frame: 1 year ]
    Determination of sustained absence of disease-specific symptoms and signs.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
4 categories:@@@@@@-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@@@@@@-Confirmed or suspected exposure to biodefense select agent, to agent of bioterrorism concern, to naturally-occurring pathogen in the environment, to emerging infectious disease agent, or to an individual suspected of harboring infection with one of these pathogens in a manner conducive to possible person-to-person transmission@@@@@@-Healthcare worker surveillance of medical staff involved in the medical care of patients in the @@@above 2 categories@@@@@@-Healthcare worker or healthy volunteer involved in simulation drills or exercises evaluating the @@@Clinical Center admission, care, and infection control processes for individuals falling into one @@@of the above categories@@@@@@@@@
Criteria
  • INCLUSION CRITERIA:

Confirmed Infection Inclusion Criteria:

  1. Laboratory diagnosis of infection by a select agent under study in a biodefense research facility, by an agent of bioterrorism, by a naturally-occurring pathogen in the environment, or by an emerging infectious disease agent, whether acute or recovering/convalescent.
  2. Clinically stable for transfer to the Clinical Center.
  3. The ability and understanding to provide written informed consent. In cases of 1) temporary incompetence due to severe illness, or 2) permanent incompetence due to a chronic condition, only persons with durable power of attorney (DPA), legal guardians, or surrogates may sign consent.

Suspected Infection Inclusion Criteria:

  1. One of the following:

    1. Close contact, within a timeframe consistent with the incubation period of an agent under study in a biodefense research facility, with an agent of bioterrorism, with a naturally-occurring pathogen in the environment, with an emerging infectious disease agent, or with a person identified as a confirmed or suspected case of contagious disease.

      • 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 identified as a suspected case of contagious disease.
      • Other contact of sufficient proximity and duration to incite reasonable concern that transmission of the causative agent of a contagious disease in the above categories may have occurred. This will be determined on an individual basis by the Principal Investigator (PI) or an Associate Investigator (AI) using best medical judgment.

      OR

    2. Penetration of the skin, within a timeframe consistent with the incubation period of a disease agent of concern, by any item with documented or suspected contamination by any agent in the above categories.

      OR

    3. Verified consumption, within a timeframe consistent with the incubation period of a disease agent of concern, of any liquid or solid with documented or suspected contamination by any agent in the categories above, whether accidental or deliberate.

      OR

    4. Verified presence, within a timeframe consistent with the incubation period of a disease agent of concern, in an area with documented or suspected release of any agent in the categories above, whether accidental or deliberate, or with endemic or enzootic foci of any of these agents above.

    AND

  2. Clinical findings consistent with infection with an agent in the categories above, whether acute or recovering/convalescent.

    AND

  3. Clinically stable for transfer to the Clinical Center.
  4. The ability and understanding to provide written informed consent. In cases of 1) temporary incompetence due to severe illness, or 2) permanent incompetence due to a chronic condition, only persons with durable power of attorney (DPA), legal guardians, or surrogates may sign consent.

Confirmed or Suspected Exposure Inclusion Criteria:

  1. One of the following:

    1. Close contact, within a timeframe consistent with the incubation period of a select agent under study in a biodefense research facility, with an agent of bioterrorism, with a naturally-occurring pathogen in the environment, with an emerging infectious disease agent, or with a person identified as a confirmed or suspected case of contagious disease.

      • 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 identified as a confirmed or suspected case of contagious disease.
      • Other contact of sufficient proximity and duration to incite reasonable concern that transmission of the causative agent of a contagious disease in the above categories may have occurred. This will be determined on an individual basis by the Principal Investigator (PI) or an Associate Investigator (AI) using best medical judgment.

      OR

    2. Penetration of the skin, within a timeframe consistent with the incubation period of a disease agent of concern, by any item with documented or suspected contamination by an agent within the categories above.

      OR

    3. Verified consumption, within a timeframe consistent with the incubation period of a disease agent of concern, of any liquid or solid with documented or suspected contamination by an agent within the categories above, whether accidental or deliberate.

      OR

    4. Verified presence, within a timeframe consistent with the incubation period of a disease agent of concern, in an area with documented or suspected release of an agent in the categories above, whether accidental or deliberate, or with endemic or enzootic foci of any of these agents above.

    AND

  2. The ability and understanding to provide written informed consent. In cases of 1) temporary incompetence due to severe illness, or 2) permanent incompetence due to a chronic condition, only persons with durable power of attorney (DPA), legal guardians, or surrogates may sign consent.

Health Care Worker Inclusion Criteria:

  1. Health care worker involved with, or anticipated to be involved with, the clinical care of above-defined patients. A health care worker is defined as anyone involved with patient care or having clinically significant patient contact.
  2. The ability and understanding to provide written informed consent.

EXCLUSION CRITERIA:

  1. Age less than 2 years.
  2. Unwillingness to enroll in a clinical research protocol governing admission and management of exposure to, or infection with, a biodefense select agent, an agent of bioterrorism concern, a naturally-occurring pathogen in the environment, or an agent of emerging infectious disease that is conducted at the NIH Clinical Center.
  3. Unwillingness to allow phlebotomy and/or storage of clinical specimens that may assist in current or future research endeavors designed to improve the diagnostic and treatment strategies relevant to the exposure or infection under consideration in the affected individual.

Information from the National Library of Medicine

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


Contacts
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Contact: Richard T Davey, M.D. (301) 496-8029 rdavey@niaid.nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Richard T Davey, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01200953     History of Changes
Other Study ID Numbers: 100197
10-I-0197
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: January 22, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Select Agents
Biosafety
Bioterrorism
SCSU (Special Clinical Studies Unit)
Infectious Disease
Bioterrorism-Related Illness
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Communicable Diseases, Emerging