Infections, Bacterial Clinical Trial
Official title:
A Phase 4, Open-label Field Study (200137) to Evaluate the Clinical Benefit, Safety and Pharmacokinetics in Subjects Treated With Raxibacumab (GSK3068483) Following Exposure to Bacillus Anthracis
This field study is designed such that it may be implemented for any individual who has been administered raxibacumab for treatment of anthrax or for post-exposure prophylaxis including sporadic cases, small anthrax incidents and/or a mass event. This study is designed to describe the clinical effectiveness (including course of illness and survival), safety profile, and raxibacumab pharmacokinetics (PK) from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data and samples for PK 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 for PK 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
The protocol is a post-marketing requirement from the FDA to evaluate the clinical benefit, safety and pharmacokinetic of raxibacumab administered to patients as part of their medical care following exposure to Bacillus anthracis. ;
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