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New study checks if botulism antidote is safe and effective for kids

NCT ID NCT02051062

Disease control Sponsor: Emergent BioSolutions Source: ClinicalTrials.gov ↗

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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at how a medicine called BAT® works in children who have or may have been exposed to botulism toxin. The medicine is an antitoxin that helps stop the toxin from causing more harm. Researchers will take blood samples from up to 10 children to see if the dose is right, and will check for side effects over 30 days. The goal is to make sure the treatment is safe and works well for kids.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 10 people

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

Started

Oct 2014

Expected to finish

Jul 2028

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.

Ages

1 day to 11 years

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. Legally authorized representative is able and willing to voluntarily provide informed consent and patients to provide assent, if applicable. 2. Pediatric participants (age groups: birth to \<two years, two to \<six years, and six to \<12 years). 3. Treatment with BAT product (initial dose only). 4. Blood sample can be collected (or standard of care sample scavenged) within 32 hours of completion of BAT product infusion. Exclusion Criteria: 1. If the 5 mL blood sample volume is deemed, at the discretion of the investigator, to be unsafe based on patient weight or condition of health. 2. History of treatment with BabyBIG or other botulism antitoxin within the past 90 days.

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Conditions

The condition(s) this trial relates to.

botulism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Botulism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.