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Enrolling by Invitation

NCT Number: NCT02051062

BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients

The purpose of this study is to verify the pediatric dosing recommendations for BAT product in pediatric patients that are treated with BAT product due to a confirmed or suspected case of botulism. A minimum of one serum sample should be collected but whenever feasible additional serum samples (up to three per enrolled participant) may be collected from the participant or obtained from surplus standard of care samples, if available, within 32 hours after BAT product administration. Safety of the BAT product will also be evaluated. Emergent will follow-up with the physician by telephone after 30 days post-BAT product administration to collect AEs, SAEs, and unanticipated events.

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Key information

Conditions

Botulism Bacterial Infections Bacterial Infections and Mycoses Chemically-Induced Disorders Clostridium Infections Foodborne Diseases Gram-Positive Bacterial Infections Infections Nervous System Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Neurotoxicity Syndromes Poisoning

Age range

1 day–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Primary Objective: To collect blood from pediatric participants to analyze the pharmacokinetics (PK) of BAT product to verify the current US FDA-approved pediatric dosing recommendations for BAT product.

Safety Objective: To evaluate the safety of BAT product in pediatric participants.

Protocol Design: This is a single arm, multi-site PK study in pediatric patients treated with BAT product.

Pharmacokinetic Parameters: The serum concentrations of BAT product obtained will be modeled using a population PK approach based on a previously developed model for BAT serotypes A through G in healthy adult human participants.

Safety Endpoints: The incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI) that occur within 30 days after BAT product administration. In this study hypersensitivity/allergic reactions including serum sickness, febrile reactions, and hemodynamic instability and bradycardia, as well as reports of an infectious disease transmission will be included as AESI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Legally authorized representative is able and willing to voluntarily provide informed consent and patients to provide assent, if applicable.
  • Pediatric participants (age groups: birth to <two years, two to <six years, and six to <12 years).
  • Treatment with BAT product (initial dose only).
  • Blood sample can be collected (or standard of care sample scavenged) within 32 hours of completion of BAT product infusion.

Exclusion criteria

  • 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.
  • History of treatment with BabyBIG or other botulism antitoxin within the past 90 days.

Treatment and study plan

Blood sample collection

Biological

One to three 5 mL blood samples will be collected from pediatric participants treated with BAT product ideally 6-24 hours after administration but within a maximum of 32 hours after administration.

Primary outcomes

  1. Margin of PK Equivalence for 90% Survival

    Time frame: ideally up to 32 hours post-BAT product administration

    Margin of PK equivalence (MOE) for 90% survival relative to the healthy adult PK model, calculated to verify the appropriateness of administered pediatric dose. All collected samples of sufficient volume will be used provided both the BAT dosing time and sample collection time are known, even if outside the 32 hour collection window.

Secondary outcomes

  1. Area Under Concentration Curve From Time 0 to Last Measurable Concentration [AUC0-t]

    Time frame: ideally up to 32 hours post-BAT product administration

    Pharmacokinetic Parameter: Estimated area under the serum concentration-time curve from time 0 to the last measurable serotype A concentration [AUC0-t]. All collected samples of sufficient volume will be used provided both the BAT dosing time and sample collection time are known, even if outside the 32 hour collection window.

  2. Area Under Concentration Curve From Time 0 to Infinity [AUC0-inf]

    Time frame: ideally up to 32 hours post-BAT product administration

    Pharmacokinetic Parameter: Estimated area under the serum concentration-time curve from time 0 to infinity [AUC0-inf]. All collected samples of sufficient volume will be used provided both the BAT dosing time and sample collection time are known, even if outside the 32 hour collection window.

  3. Between Subject Variability [BSV]

    Time frame: ideally up to 32 hours post-BAT product administration

    Pharmacokinetic Parameter: Between subject variability [BSV]. All collected samples of sufficient volume will be used provided both the BAT dosing time and sample collection time are known, even if outside the 32 hour collection window.

  4. Maximum Serum Serotype A Concentration [Cmax]

    Time frame: ideally up to 32 hours post-BAT product administration

    Pharmacokinetic Parameters: Estimated maximum serum serotype A concentration [Cmax]. All collected samples of sufficient volume will be used provided both the BAT dosing time and sample collection time are known, even if outside the 32 hour collection window.

  5. Systemic Clearance [CL]

    Time frame: ideally up to 32 hours post-BAT product administration

    Pharmacokinetic Parameters: Estimated systemic clearance [CL]. All collected samples of sufficient volume will be used provided both the BAT dosing time and sample collection time are known, even if outside the 32 hour collection window.

  6. Intercompartmental Clearance [CLd]

    Time frame: ideally up to 32 hours post-BAT product administration

    Pharmacokinetic Parameters: Estimated intercompartmental clearance [CLd]. All collected samples of sufficient volume will be used provided both the BAT dosing time and sample collection time are known, even if outside the 32 hour collection window.

  7. Central Volume of Distribution [Vc]

    Time frame: ideally up to 32 hours post-BAT product administration

    Pharmacokinetic Parameters: Estimated central volume of distribution [Vc]. All collected samples of sufficient volume will be used provided both the BAT dosing time and sample collection time are known, even if outside the 32 hour collection window.

  8. Peripheral Volume of Distribution [Vp]

    Time frame: ideally up to 32 hours post-BAT product administration

    Pharmacokinetic Parameters: Estimated peripheral volume of distribution [Vp]). All collected samples of sufficient volume will be used provided both the BAT dosing time and sample collection time are known, even if outside the 32 hour collection window.

Other outcomes

  1. Safety: AEs

    Time frame: Day 1 to Day 30

    Number of AEs that occur within 30 days after BAT product administration

  2. Safety: SAEs

    Time frame: Day 1 to Day 30

    Number of SAEs that occur within 30 days after BAT product administration

  3. Safety: AESI

    Time frame: Day 1 to Day 30

    Number of AESI that occur within 30 days after BAT product administration

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Registry information

Official study title

Pharmacokinetics of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) in Pediatric Patients With a Confirmed or Suspected Exposure to Botulinum Neurotoxin

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Jan 31, 2014
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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