NCT03231228

Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects

Phase 4, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Safety of 1 g of Cefazolin in Pediatric Subjects Weighing 25 to Less Than 60 kg and 2 g of Cefazolin in Pediatric Subjects Weighing at Least 60 kg Scheduled for Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: B. Braun Medical Inc. · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Postoperative Infection

Interventions

Type	Name	Description
DRUG	Cefazolin 1 g Infusion	1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg
DRUG	Cefazolin 2 g Infusion	2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg

Timeline

• Start date: 2017-11-20
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2017-07-27
• Last updated: 2020-07-13
• Results posted: 2020-03-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study