Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax

ConditionAnthrax
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEmergent BioSolutions

About this trial

This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with systemic anthrax. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and survival) and serum concentrations of AIGIV (for AIGIV pharmacokinetics) and anthrax toxins from sporadic cases of systemic anthrax patients treated with AIGIV.

Eligibility criteria

Qualifiers

Confirmed or suspected systemic anthrax patients in the USA or other jurisdictions (if feasible) treated with AIGIV provided by the Centers for Disease Control and Prevention (CDC).

Informed consent/assent (as applicable).

Disqualifiers

There are no exclusion criteria for subjects enrolling in this study.

Trial design

Treatments tested in this trial

  • AIGIV

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Emergent BioSolutions

Lead sponsor

Centers for Disease Control and Prevention

Collaborator

Department of Health and Human Services

Collaborator