Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or … (NCT01200953) | Clinical Trial Compass
RecruitingNot Applicable
Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases
United States200 participantsStarted 2011-08-04
Plain-language 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 3 years of age who have confirmed or suspected infection by a biodefense or bioterrorism agent, or an emerging infectious disease agent.
* Individuals at least 3 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.
Who can participate
Age range
3 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Clinically stable for transfer to the Clinical Center.
. One of the following:
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptoms and signs
Timeframe: 1 year
Trial details
NCT IDNCT01200953
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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.
. 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.
. Clinical findings consistent with infection with an agent in the categories above, whether acute or recovering/convalescent.
Exclusion criteria
. Age \< 3 years or otherwise not conforming to NIH Clinical Center rules governing pediatric admissions.
. Unwillingness to comply with protocol requirements.