About this trial
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and survival) and serum concentrations of AIGIV (for AIGIV pharmacokinetics) and anthrax toxins from inhalational anthrax patients treated with AIGIV.
Eligibility criteria
Qualifiers
Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.
Treatment with AIGIV.
Informed consent/assent (as applicable).
Disqualifiers
There are no exclusion criteria for subjects enrolling in this study.
Trial design
Treatments tested in this trial
- AIGIV
Treatment groups
Locations
Sponsors and collaborators
Emergent BioSolutions
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Department of Health and Human Services
Collaborator