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

Phase 4Not Yet RecruitingNCT02177721

Emergent BioSolutions100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Interventions

Sample CollectionBIOLOGICAL

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Up to Day 29

Secondary Outcomes

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.