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NCT Number: NCT02177721

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

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.

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Key information

Conditions

Infections, Bacterial Anthrax Bacillaceae Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sample Collection

Biological

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.

Primary outcomes

  1. Evaluate Clinical Benefit of Raxibacumab for Patients with Symptomatic Inhalational Anthrax

    Time frame: Up to Day 29

    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.

Secondary outcomes

  1. Evaluate Safety of Raxibacumab for Patients with Symptomatic Inhalational Anthrax

    Time frame: Up to Day 29

    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.

Other outcomes

  1. Evaluate the Clinical Course of Disease

    Time frame: Up to Day 29

    To evaluate the clinical course of the disease in patients with inhalational anthrax disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Development Representative

CONTACT

[email protected]

(204) 275-4196

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority
  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2035
Study completion
2035
First posted
Jun 30, 2014
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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