Inhalational AnthraxNCT03569553
A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
An observational study of Inhalational Anthrax, run by Emergent BioSolutions.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inhalational Anthrax
- What is being tested?
- AIGIV
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2027to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inhalational anthrax patients who have received AIGIV.
Who may be able to join
- Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.
- Treatment with AIGIV.
- Informed consent/assent (as applicable).
Who cannot join
- There are no exclusion criteria for subjects enrolling in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Inhalational Anthrax
- Being tested
- AIGIV
- Keywords
- Anthrax, Bacillus anthracis, Inhalational anthrax, Bacterial infection, AIGIV, Anthrasil, Anthrax immune globulin, Anti toxin, Polyclonal antibodies
- Medical subject headings
- Inhalation anthrax, Anthrax, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIGIVDrug
Also called ANTHRASIL®
Anthrax Immune Globulin Intravenous (Human)
| Study group | Role | What they receive |
|---|---|---|
| AIGIV | Inhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information. Receives: Drug: AIGIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to Day 30
Secondary outcomes (4)
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
Measured: Up to Day 30
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
Measured: 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 (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
Measured: 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
Measured: Up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start30 May 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalational AnthraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention, Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Brandon Essink, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569553
- Sponsor's protocol ID
- AX-003A
- Status last verified
- Feb 2026
- First submitted
- 15 Jun 2018
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03569553
- Acronym / sponsor ID
- AX-003A
- Conditions
- Inhalational Anthrax
- Keywords
- Anthrax, Bacillus anthracis, Inhalational anthrax, Bacterial infection, AIGIV, Anthrasil, Anthrax immune globulin, Anti toxin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention, Department of Health and Human Services
- Study start
- 30 May 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIGIV | – | Drug: AIGIVInhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inhalational anthrax patients who have received AIGIV.
Key inclusion criteria (3 listed)
- Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.
- Treatment with AIGIV.
- Informed consent/assent (as applicable).
Key exclusion criteria (1 listed)
- There are no exclusion criteria for subjects enrolling in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIGIVAlso: ANTHRASIL®Anthrax Immune Globulin Intravenous (Human) | Drug | AIGIV |
Primary outcome
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
4 secondary outcomes
Assessment of AIGIV clinical benefit by time from symptom onset to death
Time frame: Up to Day 30
Assessment of AIGIV clinical benefit by mortality rate at Day 7 and Day 30
Time frame: 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
Mortality rate stratified by number of AIGIV doses administered
Time frame: Up to Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.
Anthrax
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandon Essink, MD principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Inhalational Anthrax, run by Emergent BioSolutions.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Development Representative (240-631-3200, ctgov@ebsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of AIGIV clinical benefit by overall mortality rate (time frame: Up to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.