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

Inhalational Anthrax Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03569553
• Other study ID #: AX-003A
• Status: Not yet recruiting
• Start date: February 11, 2025
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Emergent BioSolutions
• Contact: Gideon Akintunde, MD
• Phone: 204 275 4060
• Email: AkintunG[@]ebsi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anthrax
• Inhalational Anthrax
• Respiratory Tract Infections

Intervention

Drug:
• AIGIV
Anthrax Immune Globulin Intravenous (Human)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Emergent BioSolutions	Centers for Disease Control and Prevention, Department of Health and Human Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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	Up to Day 30
Other	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
Other	Duration of hospitalization	Length of hospitalization in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV	Up to Day 30
Other	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
Other	Incidence of ICU hospitalization	Number of patients with confirmed diagnosis of inhalational anthrax treated with AIGIV admitted to ICU	Up to Day 30
Other	Duration of mechanical ventilation	Length of mechanical ventilation in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV	Up to Day 30
Other	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	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	Up to Day 30
Secondary	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
Secondary	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