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Anthrax drug under the microscope: new study tracks Real-World use

NCT ID NCT07478471

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2027

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

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.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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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