Clinical Benefit, Safety and PK of Raxibacumab in Subjects Exposed to Bacillus Anthracis

Launched by EMERGENT BIOSOLUTIONS · Jun 26, 2014

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called raxibacumab for people who have been exposed to anthrax, a serious bacterial infection. The study aims to gather information on how well the drug works, how safe it is, and how it behaves in the body after treatment. This research will help doctors understand the best ways to care for patients who may have been exposed to anthrax, whether it's from a small incident or a larger outbreak.

Anyone who receives raxibacumab for anthrax treatment can take part in this study, including men, women (even those who are pregnant or breastfeeding), and children of all ages. Participants or their caregivers will need to agree to the study and provide written consent. There are no specific health conditions that would exclude someone from joining. While the study will collect information both during and after treatment, it is important to note that data may be gathered retrospectively, especially in the event of a large anthrax exposure. This means that researchers will also look back at patients' records to gather important information. Overall, this study is a valuable opportunity to improve how anthrax is treated in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Women-including pregnant and lactating women, men, and children of all ages who receive treatment with raxibacumab as part of their clinical care for anthrax infection or for post-exposure prophylaxis will be eligible to enroll in this study.
• • Subjects willing and able to adhere to the procedures stated in the protocol
• • Subjects or legally acceptable representative of minors and unconscious adults willing and able to give written informed consent to participate in the study.
• Exclusion Criteria:
• • There are no exclusion criteria for subjects enrolling in this study.