A Phase 4 interventional study of Blood sample collection in Botulism, sponsored by Emergent BioSolutions. Enrolling by invitation. Open to participants aged 1 Day to 11 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Emergent BioSolutions · Phase 4, Interventional, and Basic science
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.
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.
20 studies on the registry are indexed under Botulism; 3 are open to participants now.
This study's planned enrollment of 10 is below the median of 29 across 14 interventional studies indexed under Botulism.
Browse Botulism studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: ideally up to 32 hours post-BAT product administration
Area Under Concentration Curve From Time 0 to Last Measurable Concentration [AUC0-t]
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.
Time frame: ideally up to 32 hours post-BAT product administration
Area Under Concentration Curve From Time 0 to Infinity [AUC0-inf]
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.
Time frame: ideally up to 32 hours post-BAT product administration
Between Subject Variability [BSV]
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.
Time frame: ideally up to 32 hours post-BAT product administration
Maximum Serum Serotype A Concentration [Cmax]
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.
Time frame: ideally up to 32 hours post-BAT product administration
Systemic Clearance [CL]
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.
Time frame: ideally up to 32 hours post-BAT product administration
Intercompartmental Clearance [CLd]
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.
Time frame: ideally up to 32 hours post-BAT product administration
Central Volume of Distribution [Vc]
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.
Time frame: ideally up to 32 hours post-BAT product administration
Peripheral Volume of Distribution [Vp]
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.
Time frame: ideally up to 32 hours post-BAT product administration
Safety: AEs
Number of AEs that occur within 30 days after BAT product administration
Time frame: Day 1 to Day 30
Safety: SAEs
Number of SAEs that occur within 30 days after BAT product administration
Time frame: Day 1 to Day 30
Safety: AESI
Number of AESI that occur within 30 days after BAT product administration
Time frame: Day 1 to Day 30
No study locations are listed for this record.
Plan to share: No
Started Oct 2014 (actual). Primary completion is estimated for Jul 2028, 165 months after the start.
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