Infections, BacterialPhase 4NCT02177721
Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario
A Phase 4 study testing Sample Collection in people with Infections, Bacterial, run by Emergent BioSolutions.
Trial summary
This field study is designed such that it may be implemented for any individual with symptomatic inhalational anthrax who has been administered raxibacumab for treatment of anthrax following a mass exposure scenario. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections, Bacterial
- What is being tested?
- Sample Collection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2035
- Phase
- Phase 4
- 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
Who may be able to join
- Symptomatic inhalational anthrax linked to an identified mass exposure to B. anthracis.
- Women, including pregnant and lactating women, men, and children of all ages who receive a dose of raxibacumab from the Strategic National Stockpile (SNS) as part of their clinical care for symptomatic inhalational anthrax will be eligible to enroll in this study.
- Patients willing and able to adhere to the procedures stated in the protocol.
- Patients (or legally acceptable representative of minors and unconscious adults) willing and able to give written informed consent/assent (as applicable) to participate in the study.
Who cannot join
- There are no exclusion criteria for patients 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 to Evaluate the Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario
This field study is designed such that it may be implemented for any individual with symptomatic inhalational anthrax who has been administered raxibacumab for treatment of anthrax following a mass exposure scenario. This study is designed to describe the clinical effectiveness (including course of illness and survival) and safety profile from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study is anticipated to be collected retrospectively. During such a mass anthrax event, scavenged blood samples will be utilized where possible to maximize sample analyses and other investigational parameters. Therefore, both retrospective and prospective data collection are allowed in this protocol in order to maximize the amount of information obtained in subjects who have been administered raxibacumab. This field study will be the first opportunity to collect data on B. anthracis-exposed patients treated with raxibacumab, to better understand the clinical benefit and safety of the drug and to further inform patient care and treatment choices for management of anthrax.
Read the detailed description
The protocol is a post-marketing requirement from the FDA to evaluate the clinical benefit and safety of raxibacumab administered to patients with symptomatic inhalational anthrax as part of their medical care following a mass exposure scenario to Bacillus anthracis.
- Conditions
- Infections, Bacterial
- Being tested
- Sample Collection
- Keywords
- Raxibacumab, anthrax, anti-toxin
- Medical subject headings
- Bacterial Infections, Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample CollectionBiological
Whenever possible serum samples will be collected from all subjects to determine serum raxibacumab concentrations pre-infusion, and at specific timepoints post-infusion. In the event cerebrospinal fluid (CSF), pleural, ascites, or bronchoalveolar lavage (BAL) fluid are collected for ad hoc clinical laboratory testing, any remaining excess sample will be provided to Sponsor for determination of raxibacumab concentrations.
Any available serum remaining from ad hoc clinical laboratory specimen collections prior to raxibacumab administration will be provided to Sponsor for measurement of serum PA concentrations. In addition, remaining post raxibacumab dose serum specimens may also be analyzed for lethal factor (LF) levels.
| Study group | Role | What they receive |
|---|---|---|
| Raxibacumab arm | Experimental | This is an open-label, single arm study. The study will be implemented for subjects with symptomatic inhalational anthrax who receive FDA-approved raxibacumab as part of medical treatment of anthrax following a mass exposure scenario.
Intervention: Sampling of subjects or use of subjects salvaged standard of care samples may be considered for the following assessments (if available/applicable): analysis of antibodies to PA (anti-PA), protective antigen (PA), and lethal factor (LF). Receives: Biological: Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Clinical Benefit of Raxibacumab for Patients with Symptomatic Inhalational Anthrax
Evaluate the clinical benefit of raxibacumab for the treatment of inhalational anthrax disease in a mass exposure scenario such as intentional B. anthracis release during a bioterrorist attack.
Measured: Up to Day 29
Secondary outcomes (1)
Evaluate Safety of Raxibacumab for Patients with Symptomatic Inhalational Anthrax
Evaluate the safety of raxibacumab for the treatment of inhalational anthrax disease in a mass exposure scenario such as intentional B. anthracis release during a bioterrorist attack.
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJan 2027 (estimated)
- Primary completionMay 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, BacterialStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention, Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Bojan Drobic, PhD, Study director, Emergent BioSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177721
- Sponsor's protocol ID
- EBS-RAX-200137a
- Status last verified
- Feb 2026
- First submitted
- 15 May 2014
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 to Evaluate the Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario
- ClinicalTrials.gov ID
- NCT02177721
- Acronym / sponsor ID
- EBS-RAX-200137a
- Conditions
- Infections, Bacterial
- Keywords
- Raxibacumab, anthrax, anti-toxin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention, Biomedical Advanced Research and Development Authority
- Study start
- Jan 2027 (estimated)
- Primary completion
- May 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 30 Jun 2014 (estimated)
- 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 field study is designed such that it may be implemented for any individual with symptomatic inhalational anthrax who has been administered raxibacumab for treatment of anthrax following a mass exposure scenario. This study is designed to describe the clinical effectiveness (including course of illness and survival) and safety profile from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study is anticipated to be collected retrospectively. During such a mass anthrax event, scavenged blood samples will be utilized where possible to maximize sample analyses and other investigational parameters. Therefore, both retrospective and prospective data collection are allowed in this protocol in order to maximize the amount of information obtained in subjects who have been administered raxibacumab. This field study will be the first opportunity to collect data on B. anthracis-exposed patients treated with raxibacumab, to better understand the clinical benefit and safety of the drug and to further inform patient care and treatment choices for management of anthrax.
Detailed description
The protocol is a post-marketing requirement from the FDA to evaluate the clinical benefit and safety of raxibacumab administered to patients with symptomatic inhalational anthrax as part of their medical care following a mass exposure scenario to Bacillus anthracis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raxibacumab arm | Experimental | Biological: Sample CollectionThis is an open-label, single arm study. The study will be implemented for subjects with symptomatic inhalational anthrax who receive FDA-approved raxibacumab as part of medical treatment of anthrax following a mass exposure scenario. Intervention: Sampling of subjects or use of subjects salvaged standard of care samples may be considered for the following assessments (if available/applicable): analysis of antibodies to PA (anti-PA), protective antigen (PA), and lethal factor (LF). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic inhalational anthrax linked to an identified mass exposure to B. anthracis.
- Women, including pregnant and lactating women, men, and children of all ages who receive a dose of raxibacumab from the Strategic National Stockpile (SNS) as part of their clinical care for symptomatic inhalational anthrax will be eligible to enroll in this study.
- Patients willing and able to adhere to the procedures stated in the protocol.
- Patients (or legally acceptable representative of minors and unconscious adults) willing and able to give written informed consent/assent (as applicable) to participate in the study.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for patients 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 |
|---|---|---|
| Sample CollectionWhenever possible serum samples will be collected from all subjects to determine serum raxibacumab concentrations pre-infusion, and at specific timepoints post-infusion. In the event cerebrospinal fluid (CSF), pleural, ascites, or bronchoalveolar lavage (BAL) fluid are collected for ad hoc clinical laboratory testing, any remaining excess sample will be provided to Sponsor for determination of raxibacumab concentrations. Any available serum remaining from ad hoc clinical laboratory specimen collections prior to raxibacumab administration will be provided to Sponsor for measurement of serum PA concentrations. In addition, remaining post raxibacumab dose serum specimens may also be analyzed for lethal factor (LF) levels. | Biological | Raxibacumab arm |
Primary outcome
Evaluate Clinical Benefit of Raxibacumab for Patients with Symptomatic Inhalational Anthrax
Time frame: Up to Day 29
Evaluate the clinical benefit of raxibacumab for the treatment of inhalational anthrax disease in a mass exposure scenario such as intentional B. anthracis release during a bioterrorist attack.
1 secondary outcome
Evaluate Safety of Raxibacumab for Patients with Symptomatic Inhalational Anthrax
Time frame: Up to Day 29
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.
- Individual participant dataSharing planned: No
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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.
Bojan Drobic, PhD study director
Emergent BioSolutions
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sample Collection in people with Infections, Bacterial, 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 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 ((204) 275-4196, ct.gov@ebsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Clinical Benefit of Raxibacumab for Patients with Symptomatic Inhalational Anthrax (time frame: Up to Day 29). 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.