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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 31, 2026

Primary Completion Date

May 31, 2035

Study Completion Date

December 31, 2035

Conditions
Infections, Bacterial
Interventions
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."

Sponsors
All Listed Sponsors
collaborator

Centers for Disease Control and Prevention

FED

collaborator

Biomedical Advanced Research and Development Authority

FED

lead

Emergent BioSolutions

INDUSTRY