An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis
Infection, Bacterial, Anthrax
About this trial
This is an interventional treatment trial for Infection, Bacterial focused on measuring Anthim®, Obiltoxaximab, anthrax, anti-toxin
Eligibility Criteria
Inclusion Criteria:
- Men and women (including pregnant and lactating women) and children of all ages who receive obiltoxaximab as part of their clinical care for anthrax infection and are willing and able to give written informed consent themselves or through legally acceptable representative (for minors, unconscious adults or deceased subjects) to participate in the study
Exclusion Criteria:
- There are no exclusion criteria defined for this study
Sites / Locations
Arms of the Study
Arm 1
Other
Obiltoxaximab
This is an open label, 24-week, single arm field study that will be implemented for subjects who receive FDA-approved obiltoxaximab as part of their medical treatment for inhalational anthrax infection in the United States. Adult subjects will be administered a single, intravenous (IV) dose of 16 mg/kg obiltoxaximab given as part of their medical care. Children will receive a weight-adjusted dose. The primary purpose of the study is to collect data from subjects who have been treated with obiltoxaximab as part of their medical care for inhalational anthrax and to collect additional blood samples for measurement of obiltoxaximab concentrations and presence of anti-therapeutic antibodies (ATA).