NCT07478471

Observational Study of Raxibacumab in Sporadic Cases of Systemic Anthrax

An Observational Clinical Study of Raxibacumab Use in Sporadic Cases of Systemic Anthrax

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This observational, open-label, single arm, study is designed such that it may be implemented for any individual with a lab confirmed sporadic case of systemic anthrax disease treated with raxibacumab outside of the current United States Prescribing Information (USPI). Systemic anthrax cases may include inhalational, gastrointestinal and injectional anthrax, anthrax meningitis or bacteremia or cutaneous anthrax with systemic effects. This study is designed to evaluate the clinical effectiveness (including course of illness and survival), safety profile and pharmacokinetic (PK) analysis of raxibacumab from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data, PK sample provision/collection and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, there is no reasonable way to identify prospectively the individuals likely to become eligible for participation in this study so most data in this study is anticipated to be collected retrospectively. 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, safety and pharmacokinetic analysis of raxibacumab administered to patients with lab confirmed systemic anthrax disease as part of their medical care following exposure to Bacillus anthracis.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
BIOLOGICAL	Collection of samples	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: 2027-05-01
• Primary completion: 2030-05-01
• Completion: 2030-12-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Regulatory

• FDA-regulated drug study