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.
Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.
Treatment with AIGIV.
Informed consent/assent (as applicable).
There are no exclusion criteria for subjects enrolling in this study.
Inhalational anthrax patients who have received AIGIV.
Cohort
Retrospective
AIGIV
DrugAnthrax Immune Globulin Intravenous (Human)
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
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
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
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
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
Cause-specific mortality rate
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
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
Number of deaths stratified by APACHE II score at baseline in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
Duration of hospitalization
Length of hospitalization in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
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Emergent BioSolutions
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Department of Health and Human Services
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
