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

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.

- 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.