Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax

Launched by EMERGENT BIOSOLUTIONS · Jun 15, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a treatment called AIGIV (ANTHRASIL®) for patients with systemic anthrax, a serious bacterial infection. The trial aims to gather information on how well AIGIV works in helping patients recover from anthrax, looking at factors like illness severity and survival rates. It will also measure how the body processes AIGIV and how it interacts with anthrax toxins. The study is open to patients in the USA who have been diagnosed or are suspected of having systemic anthrax, which can come from various sources like inhalation, ingestion, or skin contact.

If someone is eligible to participate, they must have confirmed or suspected systemic anthrax and be treated with the AIGIV provided by the Centers for Disease Control and Prevention (CDC). There are no exclusion criteria, meaning almost anyone fitting the inclusion criteria can join the study. Participants will be required to give their consent to be part of the trial and can expect to be monitored closely during their treatment. Overall, this study aims to provide valuable insights into how AIGIV can help patients fighting this serious infection.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed or suspected systemic anthrax patients in the USA or other jurisdictions (if feasible) treated with AIGIV provided by the Centers for Disease Control and Prevention (CDC).
• * Systemic anthrax defined 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:
• • Epidemiologically linked to a documented anthrax environmental exposure. Laboratory confirmation by isolation of B. anthracis from an affected tissue or site.
• • Demonstration of B. anthracis antigens in tissues by immunohistochemical staining using both B. anthracis cell wall and capsule monoclonal antibodies.
• • Evidence of B. anthracis DNA; for example, by polymerase chain reaction (PCR) in specimens collected from a normally sterile site (such as blood or cerebrospinal fluid (CSF)) or lesion of other affected tissue(s) (skin, pulmonary, reticuloendothelial, or gastrointestinal).
• • QuickELISA™ Anthrax-PA kit manufactured by Immunetics, Inc. for detection of anti-PA antibodies in serum, plasma, and pleural/ascitic fluid.
• • RedLine Alert™ test manufactured by Tetracore, Inc., for identification of B. anthracis colonies.
• • Informed consent/assent (as applicable).
• Exclusion Criteria:
• • There are no exclusion criteria for subjects enrolling in this study.