BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients

NCT02051062 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: BT-011
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Botulism

Keywords

Pharmacokinetics; BAT; Pediatric

Outcome Measures

Primary Outcomes (1)

• Margin of PK Equivalence for 90% Survival

  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.

  ideally up to 32 hours post-BAT product administration

Secondary Outcomes (8)

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

  ideally up to 32 hours post-BAT product administration

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

  ideally up to 32 hours post-BAT product administration

• Between Subject Variability [BSV]

  ideally up to 32 hours post-BAT product administration

• Maximum Serum Serotype A Concentration [Cmax]

  ideally up to 32 hours post-BAT product administration

• Systemic Clearance [CL]

  ideally up to 32 hours post-BAT product administration

Other Outcomes (3)

• Safety: AEs

  Day 1 to Day 30

• Safety: SAEs

  Day 1 to Day 30

• Safety: AESI

  Day 1 to Day 30

Study Arms (1)

Blood sample collection

EXPERIMENTAL

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.

Biological: Blood sample collection

Interventions

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.

Blood sample collection

Eligibility Criteria

• Age: 1 Day - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead

Related Publications (4)

• Richardson JS, Parrera GS, Astacio H, Sahota H, Anderson DM, Hall C, Babinchak T. Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States. Clin Infect Dis. 2020 Apr 15;70(9):1950-1957. doi: 10.1093/cid/ciz515.

  PMID: 31209461 BACKGROUND

• Parrera GS, Astacio H, Tunga P, Anderson DM, Hall CL, Richardson JS. Use of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) (BAT(R)) in Clinical Study Subjects and Patients: A 15-Year Systematic Safety Review. Toxins (Basel). 2021 Dec 27;14(1):19. doi: 10.3390/toxins14010019.

  PMID: 35050996 BACKGROUND

• Beliveau M, Anderson D, Barker D, Kodihalli S, Simard E, Hall C, Richardson JS. Exposure-Response Modeling and Simulation to Support Human Dosing of Botulism Antitoxin Heptavalent Product. Clin Pharmacol Ther. 2022 Jul;112(1):171-180. doi: 10.1002/cpt.2620. Epub 2022 May 16.

  PMID: 35467014 BACKGROUND

• Rao AK, Sobel J, Chatham-Stephens K, Luquez C. Clinical Guidelines for Diagnosis and Treatment of Botulism, 2021. MMWR Recomm Rep. 2021 May 7;70(2):1-30. doi: 10.15585/mmwr.rr7002a1.

  PMID: 33956777 BACKGROUND

MeSH Terms

Conditions

Botulism

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Development Representative

  Emergent BioSolutions

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 31, 2014
• Study Start: October 1, 2014
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share