This field study is designed such that it may be implemented for any individual with symptomatic inhalational anthrax who has been administered raxibacumab for treatment of anthrax following a mass exposure scenario. This study is designed to describe the clinical effectiveness (including course of illness and survival) and safety profile from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study is anticipated to be collected retrospectively. During such a mass anthrax event, scavenged blood samples will be utilized where possible to maximize sample analyses and other investigational parameters. Therefore, both retrospective and prospective data collection are allowed in this protocol in order to maximize the amount of information obtained in subjects who have been administered raxibacumab. This field study will be the first opportunity to collect data on B. anthracis-exposed patients treated with raxibacumab, to better understand the clinical benefit and safety of the drug and to further inform patient care and treatment choices for management of anthrax.
Symptomatic inhalational anthrax linked to an identified mass exposure to B. anthracis.
Women, including pregnant and lactating women, men, and children of all ages who receive a dose of raxibacumab from the Strategic National Stockpile (SNS) as part of their clinical care for symptomatic inhalational anthrax will be eligible to enroll in this study.
Patients willing and able to adhere to the procedures stated in the protocol.
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.
There are no exclusion criteria for patients enrolling in this study.
Single group
Sample Collection
Biological/VaccineWhenever possible serum samples will be collected from all subjects to determine serum raxibacumab concentrations pre-infusion, and at specific timepoints post-infusion. In the event cerebrospinal fluid (CSF), pleural, ascites, or bronchoalveolar lavage (BAL) fluid are collected for ad hoc clinical laboratory testing, any remaining excess sample will be provided to Sponsor for determination of raxibacumab concentrations. Any available serum remaining from ad hoc clinical laboratory specimen collections prior to raxibacumab administration will be provided to Sponsor for measurement of serum PA concentrations. In addition, remaining post raxibacumab dose serum specimens may also be analyzed for lethal factor (LF) levels.
Evaluate Clinical Benefit of Raxibacumab for Patients with Symptomatic Inhalational Anthrax
Evaluate the clinical benefit of raxibacumab for the treatment of inhalational anthrax disease in a mass exposure scenario such as intentional B. anthracis release during a bioterrorist attack.
Evaluate Safety of Raxibacumab for Patients with Symptomatic Inhalational Anthrax
Evaluate the safety of raxibacumab for the treatment of inhalational anthrax disease in a mass exposure scenario such as intentional B. anthracis release during a bioterrorist attack.
Evaluate the Clinical Course of Disease
To evaluate the clinical course of the disease in patients with inhalational anthrax disease.
Click on the lead sponsor to view all of their trials.
Emergent BioSolutions
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Biomedical Advanced Research and Development Authority
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
