Anthrax secrets revealed: new study tracks infection and vaccine response

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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. 1. 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 2. 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 3. 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). 4. Exposed individuals who are clinically asymptomatic. 5. Past or imminent vaccination in healthy (non-anthrax exposed). 6. 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 7. 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.