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NCT Number: NCT03569553

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

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.

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Key information

Conditions

Inhalational Anthrax Anthrax Bacillaceae Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Inhalation anthrax

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AIGIV

Drug

Anthrax Immune Globulin Intravenous (Human)

Other names: ANTHRASIL®

Primary outcomes

  1. Assessment of AIGIV clinical benefit by overall mortality rate

    Time frame: Up to Day 30

    Mortality rate (incidence of death) in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

Secondary outcomes

  1. Assessment of AIGIV clinical benefit by time from symptom onset to death

    Time frame: Up to Day 30

    Time from symptom onset to death in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  2. Assessment of AIGIV clinical benefit by mortality rate at Day 7 and Day 30

    Time frame: Up to Day 30

    Difference in mortality rate at Day 7 and Day 30 after AIGIV administration to patients with confirmed diagnosis of inhalational anthrax

  3. Assessment of AIGIV safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions

    Time frame: Up to Day 30

    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

  4. Mortality rate stratified by number of AIGIV doses administered

    Time frame: Up to Day 30

    Number of deaths stratified by number of AIGIV doses (single versus multiple doses) in patients with confirmed diagnosis of systemic anthrax treated with AIGIV

Other outcomes

  1. Cause-specific mortality rate

    Time frame: Up to Day 30

    Number of deaths assigned to a specific cause in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  2. Mortality rate stratified by AIGIV treatment time from symptom onset

    Time frame: 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

  3. Mortality rate stratified by acute physiologic assessment and chronic health evaluation (APACHE) II score at baseline

    Time frame: Up to Day 30

    Number of deaths stratified by APACHE II score at baseline in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  4. Duration of hospitalization

    Time frame: Up to Day 30

    Length of hospitalization in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  5. Duration of intensive care unit (ICU) hospitalization

    Time frame: Up to Day 30

    Length of ICU stay in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  6. Incidence of ICU hospitalization

    Time frame: Up to Day 30

    Number of patients with confirmed diagnosis of inhalational anthrax treated with AIGIV admitted to ICU

  7. Duration of mechanical ventilation

    Time frame: Up to Day 30

    Length of mechanical ventilation in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  8. Evaluation of sequential organ failure assessment (SOFA) score

    Time frame: Up to Day 14

    Increase in SOFA score from baseline in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  9. Assessment of AIGIV pharmacokinetics

    Time frame: Up to Day 7

    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

  10. Assessment of anthrax toxin levels (protective antigen and lethal factor)

    Time frame: Up to Day 7

    Levels of anthrax toxins (protective antigen and lethal factor) over time in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Development Representative

CONTACT

[email protected]

240-631-3200

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Collaborators

  • Centers for Disease Control and Prevention
  • Department of Health and Human Services

Registry information

Official study 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

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2018
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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