- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03569553
A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
February 14, 2024 updated by: Emergent BioSolutions
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
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.
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gideon Akintunde, MD
- Phone Number: 204 275 4060
- Email: AkintunG@ebsi.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Inhalational anthrax patients who have received AIGIV.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
AIGIV
Inhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information.
|
Anthrax Immune Globulin Intravenous (Human)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to Day 30
|
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
|
Up to Day 30
|
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
|
Up to Day 30
|
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
|
Up to Day 30
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to Day 30
|
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
|
Up to Day 30
|
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
|
Up to Day 30
|
Duration of hospitalization
Time Frame: Up to Day 30
|
Length of hospitalization in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
|
Up to Day 30
|
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
|
Up to Day 30
|
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
|
Up to Day 30
|
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
|
Up to Day 30
|
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
|
Up to Day 14
|
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
|
Up to Day 7
|
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
|
Up to Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brandon Essink, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 11, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
June 15, 2018
First Submitted That Met QC Criteria
June 15, 2018
First Posted (Actual)
June 26, 2018
Study Record Updates
Last Update Posted (Actual)
February 15, 2024
Last Update Submitted That Met QC Criteria
February 14, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AX-003A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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