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

Postoperative Infection Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03231228
Study type Interventional
Source B. Braun Medical Inc.
Contact
Status Terminated
Phase Phase 4
Start date November 20, 2017
Completion date July 31, 2019
View Details
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