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.
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).
There are no exclusion criteria for subjects enrolling in this study.
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 systemic anthrax treated with AIGIV
Assessment of AIGIV safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions
Combined incidence of serious adverse drug reactions (i.e. serious adverse events related to AIGIV administration) and serious suspected adverse drug reactions (i.e. serious adverse events that occur during or within 24 hours following AIGIV administration) in individuals treated with AIGIV
Cause-specific mortality rate
Number of deaths assigned to a specific cause in patients with confirmed diagnosis of systemic anthrax 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
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 systemic 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 systemic 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:
