AnthraxNCT03569514
Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax
An observational study of Anthrax, run by Emergent BioSolutions.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anthrax
- What is being tested?
- AIGIV
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to Aug 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: Anthrax patients who have received AIGIV.
Who may be able to join
- Confirmed or suspected systemic anthrax patients in the USA or other jurisdictions (if feasible) treated with AIGIV provided by the Centers for Disease Control and Prevention (CDC).
- Systemic anthrax defined as a clinically compatible case of gastrointestinal, injectional, or inhalational anthrax; anthrax meningitis or bacteremia; or cutaneous anthrax with systemic effects (i.e. tachycardia, tachypnea, hypotension, hyperthermia, hypothermia, leukocytosis) or with lesions that involve the head, neck or upper torso, or are large, bullous, multiple, or surrounded by significant edema PLUS confirmation by one of the following:
- 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.
- 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: An Observational Clinical Study of AIGIV Use in Sporadic Cases of Systemic Anthrax
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.
Read the detailed description
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.
- Conditions
- Anthrax
- Being tested
- AIGIV
- Keywords
- Anthrax, Bacillus anthracis, Bacterial infection, AIGIV, Anthrax immune globulin, Anti toxin, Polyclonal antibodies
- Medical subject headings
- 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 | 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 systemic anthrax treated with AIGIV
Measured: Up to Day 30
Secondary outcomes (1)
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
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 Nov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 10 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
- NCT03569514
- Sponsor's protocol ID
- AX-003B
- 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
- An Observational Clinical Study of AIGIV Use in Sporadic Cases of Systemic Anthrax
- ClinicalTrials.gov ID
- NCT03569514
- Acronym / sponsor ID
- AX-003B
- Conditions
- Anthrax
- Keywords
- Anthrax, Bacillus anthracis, Bacterial infection, AIGIV, Anthrax immune globulin, Anti toxin, Polyclonal antibodies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 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 Nov 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIGIV | – | Drug: AIGIVAnthrax 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
- Anthrax patients who have received AIGIV.
Key inclusion criteria (8 listed)
- Confirmed or suspected systemic anthrax patients in the USA or other jurisdictions (if feasible) treated with AIGIV provided by the Centers for Disease Control and Prevention (CDC).
- Systemic anthrax defined as a clinically compatible case of gastrointestinal, injectional, or inhalational anthrax; anthrax meningitis or bacteremia; or cutaneous anthrax with systemic effects (i.e. tachycardia, tachypnea, hypotension, hyperthermia, hypothermia, leukocytosis) or with lesions that involve the head, neck or upper torso, or are large, bullous, multiple, or surrounded by significant edema PLUS confirmation by one of the following:
- 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).
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 systemic anthrax treated with AIGIV
1 secondary outcome
Assessment of AIGIV safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions
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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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 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 8 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; AzTrials last refreshed its copy on 7 Nov 2026.