NCT02177721

Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario

A Field Study to Evaluate the Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The protocol is a post-marketing requirement from the FDA to evaluate the clinical benefit and safety of raxibacumab administered to patients with symptomatic inhalational anthrax as part of their medical care following a mass exposure scenario to Bacillus anthracis.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
BIOLOGICAL	Sample Collection	Whenever 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.

Timeline

• Start date: 2027-01-01
• Primary completion: 2035-05-01
• Completion: 2035-12-01
• First posted: 2014-06-30
• Last updated: 2026-02-06

Regulatory

• FDA-regulated drug study