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

This study is currently recruiting participants.
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01200953
First received: September 11, 2010
Last updated: April 2, 2014
Last verified: March 2014
  Purpose

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
Occupational Accidents
Incubation Period, Infectious Disese

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 250
Study Start Date: August 2010
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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200953

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

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Richard T Davey, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01200953     History of Changes
Other Study ID Numbers: 100197, 10-I-0197
Study First Received: September 11, 2010
Last Updated: April 2, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Select Agents
Biosafety
Bioterrorism
SCSU (Special Clinical Studies Unit)
Infectious Disease
Bioterrorism-Related Illness

Additional relevant MeSH terms:
Communicable Diseases
Infection
Communicable Diseases, Emerging

ClinicalTrials.gov processed this record on April 17, 2014