Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Dec 3, 2002

Keywords

ClinConnect Summary

This clinical trial, titled "Natural History of Anthrax," aims to better understand anthrax, a serious bacterial infection, by studying individuals who have been infected, those who have recovered, and people who may have been exposed to the bacteria. The researchers want to learn more about how the disease affects the body, the symptoms it causes, and how the immune system responds to both the infection and the anthrax vaccine (AVA). Eligible participants include those with confirmed or suspected cases of anthrax, people who have been exposed but show no symptoms, and healthy individuals who have received the anthrax vaccine.

Participants in the study will undergo various tests, including blood tests, imaging scans, and swabs to check for the presence of anthrax. Those with symptoms will receive medical care and may be offered antibiotics to prevent further infection. The study is open to individuals aged 3 years and older, including pregnant women, as long as they are stable and agree to allow their samples to be stored for research. Overall, this trial seeks to improve our understanding of anthrax and how to better prevent and treat this infection.

Gender

ALL

Eligibility criteria

• * 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.