Observational Study of Raxibacumab in Sporadic Cases of Systemic Anthrax

Inclusion Criteria

• •1. Any patient (women, including pregnant and lactating women, men, and children of all ages) with lab confirmed systemic anthrax in the US treated with a dose of raxibacumab from the Strategic National Stockpile (SNS).
• •2. Patients willing and able to adhere to the procedures stated in the protocol.
• •3. Patients (or legally acceptable representative of minors and unconscious adults) willing and able to give written informed consent/assent (as applicable) to participate in the study.
• •Note: Systemic anthrax is defined in this protocol as a clinically compatible case of gastrointestinal, injectional, or inhalational anthrax; anthrax meningitis or bacteremia; or cutaneous anthrax with systemic effects (i.e., tachycardia, tachypnea, hypotension, hyperthermia, hypothermia, leukocytosis) or with lesions that involve the head, neck or upper torso, or are large, bullous, multiple, or surrounded by significant edema; plus confirmation by one of the following: Epidemiological link to a documented anthrax environmental exposure and/or laboratory test used for confirmation of systemic anthrax diagnosis by one of the following:
• •Isolation and culture of Bacillus spp. from an affected tissue or site;
• •Evidence of Bacillus spp. DNA by PCR in biological samples such as blood or cerebrospinal fluid (CSF) or lesion of affected tissue (skin, pulmonary, reticuloendothelial, or gastrointestinal);
• •Molecular Typing by Multiple-Locus Variable number tandem repeat Analysis (MLVA); Susceptibility to lysis by γ-phage;
• •QuickELISA™ Anthrax-PA Kit- Detection of anti-PA antibodies in serum, plasma, or pleural/ascitic fluid or;
• •RedLine Alert™ Test- Qualitative identification of B. anthracis colonies