Status:
RECRUITING
Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Anthrax
Bacillus Infections
Eligibility:
All Genders
3-100 years
Brief Summary
This study will examine pathophysiology and immune response of anthrax in infected or exposed individuals to learn more about the disease symptoms, prevention and response to treatment. In addition, i...
Detailed Description
The intentional use of Bacillus anthracis in 2001 as a bioterrorism weapon with fatal consequences renewed interest in past epidemiologic and animal research about pathogenesis and posed new dilemmas ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects at least 3 years old, including pregnant women, are eligible for inclusion if they meet one of the five criteria listed below, are hemodynamically and clinically stable, and agree to stored samples. Women of child-bearing age or potential will not be excluded from participation but pregnancy status will be determined by serum or urine pregnancy test at time of enrollment in order to optimize subsequent evaluation and care.
- Although the study is open to participants at least 3 years old, pediatric anthrax cases are historically rare and essentially of the cutaneous type. Therefore, few, if any pediatric subjects are expected.
- Decisionally impaired subjects will be included in this study only if a Legally Authorized Representative (LAR) understands and is willing to sign a written informed consent document.
- Inhalation Anthrax (acute or recovering infection)
- CONFIRMED:
- -nonspecific febrile illness followed by sepsis and/or respiratory failure
- AND
- -B anthracis isolation (via culture) from any site OR 2 supportive lab tests
- OR SUSPECTED:
- -nonspecific febrile illness followed by sepsis and/or respiratory failure with no alternative diagnosis
- AND
- -one supportive lab test OR direct epidemiological link to a confirmed environmental exposure
- Cutaneous Anthrax (acute or recovering infection)
- CONFIRMED:
- -characteristic lesion (papule-\>vesicular-\>depressed black eschar plus or minus edema, erythema, necrosis, or ulceration)
- AND
- -B anthracis isolation (culture) from any site OR 2 supportive lab tests
- SUSPECTED:
- -Characteristic lesion with no alternative diagnosis
- AND
- -one supportive lab test OR direct epidemiological link to a confirmed environmental exposure
- Gastrointestinal Anthrax (acute or recovering infection)
- CONFIRMED:
- -Severe abdominal pain often associated with bloody vomiting/diarrhea followed by fever/septicemia
- AND
- -B anthracis isolation (culture) from any site OR 2 supportive lab tests
- SUSPECTED:
- -Severe abdominal pain often associated with bloody vomiting/diarrhea followed by fever/septicemia with no alternative diagnosis
- AND
- -1 supportive lab test OR direct epidemiological link to a confirmed environmental exposure
- These definitions were subsequently updated by the CDC in 2010 to accept clinically compatible symptoms plus one of the following: a positive culture, a positive immunohistochemical stain for antigen, a 4-fold increase in anti-PA IgG or a positive documented exposure with detection of DNA via PCR (26).
- Exposed individuals who are clinically asymptomatic.
- Past or imminent vaccination in healthy (non-anthrax exposed).
- Hemodynamically and clinically stable at time of evaluation at NIH.
- Hemodynamically: stable vital signs
- Clinically: no obvious signs of disease progression (e.g. worsening pleural effusions or increasing cutaneous edema)
- acute/newly recovered patients must be receiving standard antimicrobial therapy
- Participant agrees to stored samples.
- EXCLUSION CRITERIA:
- Inability of subject or Legally Authorized Representative (LAR) to understand or subject not willing to sign a written informed consent document.
Exclusion
Key Trial Info
Start Date :
October 31 2002
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00050310
Start Date
October 31 2002
Last Update
December 26 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892