NIH launches study to better handle bioterrorism and outbreak exposures
NCT ID NCT01200953
First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 7 times
Summary
This study aims to improve how doctors evaluate and manage people who have been exposed to bioterrorism agents (like anthrax) or emerging infectious diseases (like SARS or new flu strains). Up to 200 participants, including patients and healthcare workers, will be monitored and treated using standardized methods. The goal is to gather data to prevent illness and save lives in future outbreaks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could improve how doctors diagnose and treat rare but dangerous infections, potentially saving lives during outbreaks.
- What could go wrong
- This is an observational study, not a treatment trial. It may not lead to new therapies, and results depend on the limited number of cases available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2011
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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3 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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. Aged 18 years or older. 2. 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. 3. The ability and understanding to provide written informed consent. Healthy Volunteer: 1. Aged 18 years or older. 2. Does not have a suspected or confirmed infection or exposure 3. The ability and understanding to provide written informed consent. EXCLUSION CRITERIA: 1. Age \< 3 years or otherwise not conforming to NIH Clinical Center rules governing pediatric admissions. 2. Unwillingness to comply with protocol requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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