Botulism Clinical Trial
Official 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
Verified date | May 2024 |
Source | Emergent BioSolutions |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 10 |
Est. completion date | July 31, 2027 |
Est. primary completion date | July 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Days to 11 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Emergent BioSolutions |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety: AEs | Number of AEs that occur within 30 days after BAT product administration | Day 1 to Day 30 | |
Other | Safety: SAEs | Number of SAEs that occur within 30 days after BAT product administration | Day 1 to Day 30 | |
Other | Safety: AESI | Number of AESI that occur within 30 days after BAT product administration | Day 1 to Day 30 | |
Primary | 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 | 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. | ideally up to 32 hours post-BAT product administration | |
Secondary | 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. | ideally up to 32 hours post-BAT product administration | |
Secondary | 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. | ideally up to 32 hours post-BAT product administration | |
Secondary | 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. | ideally up to 32 hours post-BAT product administration | |
Secondary | 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. | ideally up to 32 hours post-BAT product administration | |
Secondary | 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. | ideally up to 32 hours post-BAT product administration | |
Secondary | 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. | ideally up to 32 hours post-BAT product administration | |
Secondary | 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. | ideally up to 32 hours post-BAT product administration |
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