An observational study in Anthrax, sponsored by Emergent BioSolutions. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Emergent BioSolutions · Observational
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.
This study is a post-marketing requirement from the FDA to evaluate safety and clinical benefit of AIGIV administered to systemic anthrax patients as part of their medical care after exposure to Bacillus anthracis (anthrax exposure can be via inhalation, ingestion, injection). 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, in some cases data may 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 systemic anthrax patients who have been treated with AIGIV.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's planned enrollment of 10 is below the median of 99 across 16 observational studies indexed under Anthrax.
Browse Anthrax studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Anthrax patients who have received AIGIV.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Epidemiologically linked to a documented anthrax environmental exposure. Laboratory confirmation by isolation of B. anthracis from an affected tissue or site.
Demonstration of B. anthracis antigens in tissues by immunohistochemical staining using both B. anthracis cell wall and capsule monoclonal antibodies.
Evidence of B. anthracis DNA; for example, by polymerase chain reaction (PCR) in specimens collected from a normally sterile site (such as blood or cerebrospinal fluid (CSF)) or lesion of other affected tissue(s) (skin, pulmonary, reticuloendothelial, or gastrointestinal).
QuickELISA™ Anthrax-PA kit manufactured by Immunetics, Inc. for detection of anti-PA antibodies in serum, plasma, and pleural/ascitic fluid.
RedLine Alert™ test manufactured by Tetracore, Inc., for identification of B. anthracis colonies.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information.
Drug: AIGIV
Anthrax Immune Globulin Intravenous (Human)
Also known as: ANTHRASIL®
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
Time frame: 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 (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
Time frame: Up to Day 30
Cause-specific mortality rate
Number of deaths assigned to a specific cause in patients with confirmed diagnosis of systemic anthrax treated with AIGIV
Time frame: 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
Time frame: Up to Day 30
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
Time frame: 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 systemic anthrax treated with AIGIV
Time frame: Up to Day 30
Duration of hospitalization
Length of hospitalization in patients with confirmed diagnosis of systemic anthrax treated with AIGIV
Time frame: Up to Day 30
Duration of intensive care unit (ICU) hospitalization
Length of ICU stay in patients with confirmed diagnosis of systemic anthrax treated with AIGIV
Time frame: Up to Day 30
Incidence of ICU hospitalization
Number of patients with confirmed diagnosis of systemic anthrax treated with AIGIV admitted to ICU
Time frame: Up to Day 30
Duration of mechanical ventilation
Length of mechanical ventilation in patients with confirmed diagnosis of systemic anthrax treated with AIGIV
Time frame: Up to Day 30
Evaluation of sequential organ failure assessment (SOFA) score
Increase in sequential organ failure assessment (SOFA) score from baseline in patients with confirmed diagnosis of systemic anthrax treated with AIGIV. Total SOFA score can range from 0 to 24; increase in total SOFA score suggests worse clinical outcome prediction.
Time frame: Up to Day 14
Assessment of AIGIV pharmacokinetics
Serum concentration of AIGIV over time in patients with confirmed diagnosis of systemic anthrax treated with AIGIV to determine pharmacokinetic parameters such as maximum serum concentration, area under the concentration versus time (i.e. level of AIGIV circulating over time) and clearance
Time frame: 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 systemic anthrax treated with AIGIV
Time frame: Up to Day 7
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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