This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery.
Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1 ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60 kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or gender. Additional subjects may be enrolled if necessary to ensure at least 50 evaluable subjects with complete safety data per dose group complete the study. In a subset of approximately 40 subjects, 4 PK samples will be obtained to determine the cefazolin plasma concentrations in this population.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
61
1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg
2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
Arkansas Children's Research Institute
Little Rock, Arkansas, United States
University of Missouri Health Care System
Columbia, Missouri, United States
Children's Medical Center Dallas
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of Participants With Treatment-Emergent Adverse Events [Safety]
Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.
Time frame: 8 days
Cefazolin Plasma Concentration Following Infusion
Concentrations will be determined through analysis of 4 blood samples drawn at 0.5-1, 2, 3, and 4 hours after the start of study drug infusion.
Time frame: Up to 4 hours after start of study drug infusion
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Carilion Clinic
Roanoke, Virginia, United States