Anthrax drug under the microscope: will it save lives?
NCT ID NCT03569514
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows up to 10 people with severe anthrax who receive a treatment called AIGIV. Researchers will track how many patients survive and whether the drug causes serious side effects. The goal is to learn more about how well AIGIV works and how it behaves in the body.
Why investors are watching
Emergent BioSolutions is running a small observational study of its anthrax treatment AIGIV in 10 patients with sporadic systemic anthrax. For a small-cap company, this readout matters because it could provide real-world safety and survival data that support the product's use and regulatory standing.
If it works: A positive result, showing AIGIV is safe and appears to help patients survive, could strengthen the company's position in anthrax countermeasures and reassure investors about the product's value.
If it fails: The study is tiny and observational, so even a poor outcome may not be conclusive, but any safety concern or lack of benefit could hurt confidence in the product. Trials often fail or produce unclear results, and delays in this small study could also weigh on the stock.
AI-written from the trial record. Speculative, and not investment advice.
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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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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
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
Anthrax patients who have received AIGIV.
- 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: * 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). 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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.