Evaluation and management of infections from bioterrorism and emerging diseases

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

This study is testing how to better monitor and treat people who have infections from bioterrorism or new diseases to see what works best for them.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 2 Years to 99 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT01200953 on ClinicalTrials.gov

What this trial studies

This study focuses on the evaluation and management of infections caused by bioterrorism agents and emerging infectious diseases. It aims to apply standardized methods for monitoring and treating individuals who are confirmed or suspected to be infected. The research will involve characterizing the clinical course of these infections and understanding the immune responses and diagnostic tests related to them. Participants will include those with confirmed infections, suspected infections, and close contacts of infected individuals.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 2 years and older with confirmed or suspected infections from bioterrorism agents or emerging infectious diseases.

Not a fit: Patients who do not have confirmed or suspected infections related to bioterrorism or emerging infectious diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved therapies and management strategies for infections related to bioterrorism and emerging diseases.

How similar studies have performed: Other studies have shown success in evaluating and managing emerging infectious diseases, but this specific approach to bioterrorism-related illnesses is less commonly tested.

Eligibility 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.

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 the 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.

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 PI or an 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.

Health Care Worker:

1. Health care worker from the NIH or a referring agency (e.g. USAMRIID) who is 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 \< 2 years or otherwise not conforming to NIH Clinical Center rules governing pediatric admissions.
2. Unwillingness to comply with protocol requirements.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Luca T Giurgea, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Luca T Giurgea, M.D.

Conditions: Occupational Accidents, Incubation Period, Infectious Disese, Select Agents, Biosafety, Bioterrorism, SCSU, Natural History, Infectious Disease