Anthrax drug under the microscope: new study tracks Real-World use
NCT ID NCT07478471
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This observational study will follow up to 10 people in the U.S. who have a confirmed case of systemic anthrax and are treated with the drug raxibacumab. Researchers will track survival, side effects, and drug levels in the blood to better understand how well the treatment works. Because anthrax is rare and unpredictable, most information will be gathered from medical records after treatment has already occurred.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- raxibacumab
- What this could lead to
- If successful, this study could provide real-world evidence on how well raxibacumab works against anthrax and help guide future treatment decisions.
- What could go wrong
- This is a very small observational study (only 10 patients) with no control group, so results may not be conclusive. Most data will be collected after the fact, which can limit reliability.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The population to be studied are patients with lab confirmed systemic anthrax who are treated with raxibacumab according to the USPI and distributed from the US SNS. The population may include all age categories of patients (infant, pediatric, adult \[including pregnant and lactating women\], and geriatric) with confirmed systemic anthrax in the US.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Any patient (women, including pregnant and lactating women, men, and children of all ages) with lab confirmed systemic anthrax in the US treated with a dose of raxibacumab from the Strategic National Stockpile (SNS). 2. Patients willing and able to adhere to the procedures stated in the protocol. 3. 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. Note: Systemic anthrax is defined in this protocol 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: Epidemiological link to a documented anthrax environmental exposure and/or laboratory test used for confirmation of systemic anthrax diagnosis by one of the following: * Isolation and culture of Bacillus spp. from an affected tissue or site; * Evidence of Bacillus spp. DNA by PCR in biological samples such as blood or cerebrospinal fluid (CSF) or lesion of affected tissue (skin, pulmonary, reticuloendothelial, or gastrointestinal); * Molecular Typing by Multiple-Locus Variable number tandem repeat Analysis (MLVA); Susceptibility to lysis by γ-phage; * QuickELISA™ Anthrax-PA Kit- Detection of anti-PA antibodies in serum, plasma, or pleural/ascitic fluid or; * RedLine Alert™ Test- Qualitative identification of B. anthracis colonies Exclusion Criteria: * There are no exclusion criteria for subjects enrolling in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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