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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Department of Health and Human Services | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIGIV | Inhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIGIV | Drug | Anthrax Immune Globulin Intravenous (Human) |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cause-specific mortality rate | Number of deaths assigned to a specific cause in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV | Up to Day 30 |
| Mortality rate stratified by AIGIV treatment time from symptom onset |
Inclusion Criteria:
Exclusion Criteria:
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Inhalational anthrax patients who have received AIGIV.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Representative | Contact | 240-631-3200 | ctgov@ebsi.com |
| Name | Affiliation | Role |
|---|---|---|
| Brandon Essink, MD | Principal Investigator |
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| ID | Term |
|---|---|
| C571912 | Inhalation anthrax |
| D000881 | Anthrax |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000609458 | Anthrax Immune Globulin Intravenous |
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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 |
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
| Up to Day 30 |
| Mortality rate stratified by acute physiologic assessment and chronic health evaluation (APACHE) II score at baseline | Number of deaths stratified by APACHE II score at baseline in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV | Up to Day 30 |
| Duration of hospitalization | Length of hospitalization in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV | Up to Day 30 |
| Duration of intensive care unit (ICU) hospitalization | Length of ICU stay in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV | Up to Day 30 |
| Incidence of ICU hospitalization | Number of patients with confirmed diagnosis of inhalational anthrax treated with AIGIV admitted to ICU | Up to Day 30 |
| Duration of mechanical ventilation | Length of mechanical ventilation in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV | Up to Day 30 |
| Evaluation of sequential organ failure assessment (SOFA) score | Increase in SOFA score from baseline in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV | Up to Day 14 |
| Assessment of AIGIV pharmacokinetics | 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 | Up to Day 7 |
| Assessment of anthrax toxin levels (protective antigen and lethal factor) | Levels of anthrax toxins (protective antigen and lethal factor) over time in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV | Up to Day 7 |