A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients

This study is a post-marketing requirement from the FDA to evaluate safety and clinical benefit of AIGIV administered to patients as part of their medical care after inhalational exposure to Bacillus anthracis. Study information (i.e. data on safety and clinical benefit evaluation of AIGIV up to Day 30 following administration) and patient samples (for assessment of AIGIV pharmacokinetics and anthrax toxin levels) will be collected (up to Day 7 following AIGIV administration) prospectively to the extent possible; however, due to logistical complexities that will likely occur during a mass anthrax exposure event, most data for this study will be collected retrospectively (including scavenged patient samples for assessment of serum AIGIV concentration and anthrax toxin levels). Therefore, both prospective and retrospective data collection are allowed in this study to maximize the amount of information obtained from inhalational anthrax patients who have been administered AIGIV.

• AIGIV (Drug), also known as ANTHRASIL®: Anthrax Immune Globulin Intravenous (Human)

Primary outcomes

• Assessment of AIGIV clinical benefit by overall mortality rate [Up to Day 30]: Mortality rate (incidence of death) in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

Secondary outcomes

• Assessment of AIGIV clinical benefit by time from symptom onset to death [Up to Day 30]: Time from symptom onset to death in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
• Assessment of AIGIV clinical benefit by mortality rate at Day 7 and Day 30 [Up to Day 30]: Difference in mortality rate at Day 7 and Day 30 after AIGIV administration to patients with confirmed diagnosis of inhalational anthrax
• Assessment of AIGIV safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions [Up to Day 30]: Combined incidence of serious adverse drug reactions (ie, serious adverse events related to AIGIV administration) and serious suspected adverse drug reactions (ie, serious adverse events that occur during or within 24 hours following AIGIV administration) in individuals treated with AIGIV
• Mortality rate stratified by number of AIGIV doses administered [Up to Day 30]: Number of deaths stratified by number of AIGIV doses (single versus multiple doses) in patients with confirmed diagnosis of systemic anthrax treated with AIGIV

Other outcomes

• Cause-specific mortality rate [Up to Day 30]: Number of deaths assigned to a specific cause in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
• Mortality rate stratified by AIGIV treatment time from symptom onset [Up to Day 30]: Number of deaths stratified by AIGIV treatment time from symptom onset (early versus late onset of symptoms) in patients with confirmed diagnosis of inhalational anthrax
• Mortality rate stratified by acute physiologic assessment and chronic health evaluation (APACHE) II score at baseline [Up to Day 30]: Number of deaths stratified by APACHE II score at baseline in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
• Duration of hospitalization [Up to Day 30]: Length of hospitalization in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
• Duration of intensive care unit (ICU) hospitalization [Up to Day 30]: Length of ICU stay in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
• Incidence of ICU hospitalization [Up to Day 30]: Number of patients with confirmed diagnosis of inhalational anthrax treated with AIGIV admitted to ICU
• Duration of mechanical ventilation [Up to Day 30]: Length of mechanical ventilation in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
• Evaluation of sequential organ failure assessment (SOFA) score [Up to Day 14]: Increase in SOFA score from baseline in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
• Assessment of AIGIV pharmacokinetics [Up to Day 7]: Serum concentration of AIGIV over time in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV to determine AIGIV pharmacokinetic parameters such as maximum serum concentration, area under the concentration versus time (i.e, level of AIGIV circulating over time) and clearance
• Assessment of anthrax toxin levels (protective antigen and lethal factor) [Up to Day 7]: Levels of anthrax toxins (protective antigen and lethal factor) over time in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

Sex: All

Inclusion Criteria:

* Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.
* Treatment with AIGIV.
* Informed consent/assent (as applicable).

Exclusion Criteria:

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

• Brandon Essink, MD, Principal investigator