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

Emergent BioSolutions

Status and phase: Begins enrollment in 10 months; Phase 4

Conditions: Infections, Bacterial

Treatments: Biological: Sample Collection

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02177721

EBS-RAX-200137a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• There are no exclusion criteria for patients enrolling in this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Raxibacumab arm

Experimental group

Description:

This is an open-label, single arm study. The study will be implemented for subjects with symptomatic inhalational anthrax who receive FDA-approved raxibacumab as part of medical treatment of anthrax following a mass exposure scenario. Intervention: Sampling of subjects or use of subjects salvaged standard of care samples may be considered for the following assessments (if available/applicable): analysis of antibodies to PA (anti-PA), protective antigen (PA), and lethal factor (LF).

Treatment:

Biological: Sample Collection