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

Study Overview
=================
Brief Summary
-----------------
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event. 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 inhalational anthrax patients treated with AIGIV.

Detailed Description
-----------------
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.

Official Title
-----------------
A Field Study for the Evaluation of AIGIV Clinical Benefit and Safety in the Treatment of Patients With Inhalational Anthrax in a Broad Exposure Event Scenario

Conditions
-----------------
Inhalational Anthrax

Intervention / Treatment
-----------------
* Drug: AIGIV


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AIGIV<br>Inhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information. | Drug: AIGIV<br>* Anthrax Immune Globulin Intravenous (Human)<br>* Other names: ANTHRASIL®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of AIGIV clinical benefit by overall mortality rate | Mortality rate (incidence of death) in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV | Up to Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of AIGIV clinical benefit by time from symptom onset to death | Time from symptom onset to death in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV | Up to Day 30 | 
| Assessment of AIGIV clinical benefit by mortality rate at Day 7 and Day 30 | Difference in mortality rate at Day 7 and Day 30 after AIGIV administration to patients with confirmed diagnosis of inhalational anthrax | Up to Day 30 | 
| Assessment of AIGIV safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions | 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 | Up to Day 30 | 
| Mortality rate stratified by number of AIGIV doses administered | Number of deaths stratified by number of AIGIV doses (single versus multiple doses) in patients with confirmed diagnosis of systemic anthrax treated with AIGIV | Up to Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anthrax, Bacillus anthracis, Inhalational anthrax, Bacterial infection, AIGIV, Anthrasil, Anthrax immune globulin, Anti toxin, Polyclonal antibodies